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- 2026-07-22 03:12:20
- Policy
- MFDS grants GIFT to 'rusfertide,' no records of any global approvals
- by Lee, Tak-Sun Jun 24, 2026 09:19am
- A new drug that would be a novel treatment option for patients with polycythemia vera (PV), a type of rare hematologic malignancy, has entered the fast-track review of the regulatory agency in South Korea. Notably, as this drug has not yet received final approval even in major global markets such as the United States and Europe, the medical community is closely watching its domestic approval and launch timeline.The Ministry of Food and Drug Safety (MFDS) announced that it has designated 'rusfertide' a polycythemia vera treatment under development by Takeda Pharmaceuticals Korea, as the 71st product under the Global Innovative Products Fast-Track (GIFT) program. The designation date was June 10.The MFDS specified that rusfertide's GIFT designation falls under the category of "no existing treatment." This decision is an outcome of a high evaluation of the drug's potential to improve efficacy and safety in a rare disease area characterized by significant unmet medical needs or where conventional therapies fail to provide adequate clinical outcomes.'Polycythemia vera (PV)', the target indication for rusfertide, is a chronic myeloproliferative neoplasm (a rare blood cancer) in which red blood cells proliferate uncontrollably in the bone marrow. An excess of red blood cells increases blood viscosity abnormally, exponentially elevating the risk of thrombosis (blood clots) that can lead to fatal complications such as stroke, myocardial infarction, and pulmonary embolism. Furthermore, it is a debilitating disease that severely compromises patients' quality of life through symptoms like chronic fatigue, generalized pruritus, and enlarged spleen.Previously, patients had to rely on therapeutic phlebotomy, requiring periodic hospital visits to draw large volumes of blood to reduce elevated red blood cell counts. However, this approach has been a significant burden, causing physical and psychological distress to patients.Rusfertide is a novel therapeutic developed to address the limitations of these conventional treatments fundamentally. It mimics hepcidin, an endogenous hormone that regulates iron metabolism in the human body. Inhibiting ferroportin, a protein that exports iron from cells into the bloodstream, blocks the iron supply required for bone marrow to produce red blood cells, thereby preventing the overproduction of erythrocytes. According to clinical studies, the drug reduces the frequency of phlebotomy sessions, significantly improving patients' quality of life.Notably, rusfertide is still an 'early-stage novel drug' that has not yet secured final regulatory approval from any major global regulatory agency.According to the expedited review report, rusfertide's innovativeness was recognized early on in the global market, receiving Fast Track (FT) and Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) and being admitted into the European Medicines Agency's (EMA) PRIME (PRIority MEdicines) program. It has also been granted Orphan Drug Designation (ODD) across South Korea, the US, and Europe. However, its official approval date remains listed as 'Not Applicable' across all global regulatory agencies, including the US, Europe, and Japan, meaning it is currently an unapproved agent undergoing regulatory review.An industry insider said, "It is both unusual and encouraging that an innovative novel drug, which has not yet achieved final approval even from leading regulatory bodies like the US FDA, has been designated under the Korean GIFT program. Thanks to the MFDS's Fast Track review support, domestic patients are expected to access this innovative therapeutic benefit relatively quickly compared to its global launch timeline."Meanwhile, based on the GIFT designation, the MFDS plans to promptly initiate its review upon submission of the marketing authorization application for rusfertide. However, the MFDS added, "The exact indications, efficacy, and safety profile will be finalized following a review during the main regulatory approval procedure."
- Company
- Three Korean companies rename Vemlidy generic products
- by Kim, Jin-Gu Jun 24, 2026 09:19am
- Daewoong Pharmaceutical, Dong-A ST, and Samil Pharmaceutical have consecutively changed the brand names of their generic versions of the hepatitis B treatment ‘Vemlidy (tenofovir alafenamide).’ The move is interpreted as the result of their final defeat in a trademark dispute with the originator company that reached the Supreme Court.According to industry sources on June 23, Dong-A ST changed the name of its product from ‘Vemlia Tab’ to ‘Tafria Tab’ effective June 22. On the same day, Samil Pharmaceutical changed ‘Vemlino Tab’ to ‘Teno-S Tab.’ Earlier, on June 16, Daewoong Pharmaceutical changed ‘Vemliver Tab’ to ‘Tafvir Tab.’As a result, three Vemlidy generics have undergone brand name changes one after another. The changes stem from the companies’ final defeat in a trademark dispute with the original manufacturer.Photos of Dong-A ST’s Vemlia, Samil Pharmaceutical’s Vemlino, and Daewoong Pharmaceutical’s Vemliver. The products have been renamed Tafria, Teno-S, and Tafvir, respectively.In July 2023, originator company Gilead Sciences filed trademark invalidation actions against the three companies, approximately four months after the generics received marketing approval. Gilead argued that the three-syllable element “Vemli” that appears in both the originator product Vemlidy and the three generic product names could cause trademark confusion.In April last year, the Intellectual Property Trial and Appeal Board ruled in favor of the generic manufacturers. The board concluded that, given the nature of prescription drugs prescribed and dispensed by healthcare professionals such as physicians and pharmacists, the likelihood of confusion or misunderstanding is low, and that the trademark should be perceived as a distinct coined term.Gilead appealed the decision to the Patent Court. In February this year, the Patent Court overturned the earlier ruling, finding that the generic product names were similar to the originator brand name and could create confusion.Following their loss in the second instance court, the generic manufacturers appealed to the Supreme Court. On the 11th, the Supreme Court dismissed the appeals without substantive review. This court’s dismissal without merit refers to a process where the Supreme Court upholds the lower court’s judgment without reviewing the case on its merits.Following their final defeat, the generic manufacturers had little choice but to change their product names, as continuing to market the products under the disputed names could be interpreted as trademark infringement. This ultimately led to the successive rebranding of all three products.The three companies now face the challenge of rebuilding brand recognition from scratch. They had spent nearly three years marketing the products under their previous names and establishing awareness among prescribers. In addition, the companies must undergo a series of administrative procedures, including changing product names in MFDS-approved labels, revising names on HIRA’s reimbursement listings, and replacing packaging materials and package inserts already in circulation.The pharmaceutical industry's attention is now focused on whether the other generic products, which did not adopt the 'Vemli-' prefix from the beginning, will benefit from this outcome. These include Chong Kun Dang’s Tenofobell-A, Hutecs Korea’s ‘Ganelid,’ Dongkook Pharmaceutical’s ‘Alfoterin,’ Samjin Pharmaceutical’s ‘Taflead,’ and Jeil Pharmaceutical’s ‘ Tecavir-D Tab.’ Gilead has not filed for the invalidation of the trademark rights for these products.Coincidentally, the three companies that lost the trademark dispute had held the top three prescription rankings among Vemlidy generics. According to pharmaceutical market research firm UBIST, the 2025 prescription sales of Samil Pharmaceutical’s Vemlino (rebranded as Teno-S) increased by 59% YoY to KRW 3.8 billion, Dong-A ST’s Vemlia (rebranded as Tafria) by 66% to KRW 2.9 billion, and Daewoong Pharmaceutical’s Vemliver (rebranded as Tafvir) by 93% to KRW 1.3 billion. In contrast, all remaining competing products recorded annual prescription sales of less than KRW 500 million.Vemlidy is a novel hepatitis B treatment developed by Gilead as the successor to Viread. Although Viread demonstrated strong antiviral efficacy against the hepatitis B virus, concerns remained regarding side effects such as renal impairment and reductions in bone mineral density. Vemlidy was developed to address these shortcomings. Clinical studies showed no significant occurrence of renal dysfunction or bone mineral density loss. The defining strength of this treatment lies in its proven long-term safety, given the chronic nature of hepatitis B and the need for prolonged treatment.Among major originator hepatitis B therapies, Vemlidy remains the only product that continues to grow. Prescription sales reached KRW 76.9 billion last year, an 8% increase YoY. In the first quarter of this year, sales rose 12% YoY to KRW 19.8 billion.
- Policy
- Mexico fast-tracks Korean drug approvals
- by Lee, Jeong-Hwan Jun 24, 2026 09:19am
- Pharmaceuticals that have received marketing authorization from Korea’s Ministry of Food and Drug Safety (MFDS) will now benefit from simplified review and approval procedures in Mexico.Approvals may be granted in as little as 45 business days, following Mexico’s decision to officially recognize the MFDS as a Reference Regulatory Authority (RRA) for pharmaceuticals.Accelerated approval and review processes in Mexico are expected to create a more favorable environment for the export of domestic pharmaceuticals.On June 23, the MFDS announced that Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has formally recognized the Korean regulator as an RRA in the pharmaceutical sector.As a result, medicines already approved in Korea can now apply for marketing authorization in Mexico through the Abbreviated Regulatory Pathway (ARP) based on Korea’s RRA recognition. This pathway is expected to simplify technical reviews related to quality, safety, and efficacy while significantly shortening approval timelines.Mexican regulators currently operate an expedited approval system that relies on regulatory decisions made by agencies that are either founding or standing members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), or are included on the World Health Organization’s WHO-Listed Authority (WLA) list.Last year, the MFDS achieved full WLA designation across all functions for pharmaceuticals and vaccines, reinforcing its international regulatory credibility.Under the abbreviated pathway, products approved by the MFDS may receive a regulatory decision in Mexico within 45 business days. COFEPRIS allows for the use of assessment results given by the reference authority and focuses primarily on verifying the completeness of submitted documentation, without requiring additional technical reviews or further data.Mexico also recognizes Good Manufacturing Practice (GMP) certificates issued by regulatory authorities listed under the WHO WLA framework that possess inspection capabilities; consequently, local firms can utilize their MFDS-issued GMP certificates for market access.Mexico is considered the second-largest pharmaceutical market in Latin America after Brazil. The MFDS expects the recognition to support the expansion of Korean pharmaceutical exports into Latin America and enhance the global competitiveness of domestic drugmakers. The Korean pharmaceutical industry likewise views the measure as a potential gateway for broader expansion throughout the Latin American region.MFDS Minister Yu-Kyoung Oh said, “Mexico’s recognition of the MFDS as a reference regulatory authority is a meaningful achievement that once again confirms the excellence and international credibility of Korea’s regulatory system. We will continue to expand global regulatory cooperation so that high-quality Korean medical products can enter overseas markets more quickly.”Yun-hong Noh, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), stated, “Korean pharmaceutical companies have long faced challenges in the Mexican approval process, and this measure is expected to enable much faster approvals. We hope this serves as a catalyst for broader market expansion in Mexico and throughout Latin America.”Mexico is the eighth country to recognize the MFDS as a reference regulatory authority, following the Philippines, Paraguay, Egypt, Ecuador, Nigeria, the United Arab Emirates (UAE), and Lebanon.
- InterView
- [Reporter's View] What is lacking in the trend of AI pathology?
- by Hwang, byoung woo Jun 24, 2026 09:18am
- Personally, I first encountered the topic of digital pathology in 2019 while entering the healthcare sector. At the time, the Korean Society of Pathologists was labeled of being a specialty avoided by medical residents, prompting intense discussions on restructuring training paradigms while simultaneously exploring ways to integrate artificial intelligence (AI).The primary objective was to overcome the stereotype of pathology being a legacy specialty destined to fall behind in the AI era, and to establish a robust foundation for big data collection and research through virtualization. Furthermore, these discussions extended to securing health insurance reimbursement for digital pathology implementation.Back then, the major hurdle to digital pathology adoption was hospital demand. In the absence of a dedicated reimbursement code, only a handful of large medical institutions could afford to acquire such expensive hardware and software systems. Even the major tertiary hospitals, the so-called 'Big 5' in South Korea, were highly conservative about implementation.As the "Major AI Transition" topic spread, "AI" naturally became the first word that came to mind when discussing digital pathology. It easily conjures images of glass slides being digitized into high-resolution images, AI identifying malignant cells, and algorithms assisting pathologists in their readings. Medical AI developers frequently pitch their technological competitiveness using words such as lesion detection, biomarker analysis, and support for companion diagnostics (CDx).However, field reports on digital pathology indicate that industry insiders still place far greater emphasis on Digital Transformation (DX) than on AI Transformation (AX). In other words, before moving to the stage of using AI for lesion detection and diagnostic support, the foundational pathology workflow must be re-engineered to fit a digital environment.For pathology AI to function optimally, certain prerequisites must be met. The entire pathology lifecycle, from specimen accessioning, slide preparation, scanning, and storage to interpretation, reporting, and hospital information system (HIS) integration, must be digitally structured. Merely scanning glass slides into image files is insufficient. There must be full traceability of how a specimen was processed and how that processing correlates with specific images and diagnostic outcomes.Unlike radiology, which underwent digital transformation relatively early, backed by PACS (Picture Archiving and Communication System), the field of pathology remains heavily dependent on analog processes. Pathology images are large, and color reproduction and standardization pose significant technical challenges. Furthermore, interoperability suffers when equipment and software architecture vary across different hospital networks. Compounded by high initial capital expenditures (CapEx), ongoing maintenance costs, a lack of institutional reimbursement, and friction with staff adaptation, transitioning to digital pathology is far from a straightforward decision for hospital leadership.Skipping this foundational gap to focus prematurely on AI disrupts the industry. If AI solutions are pushed forward without sufficient digital infrastructure deployed at the clinical site, their real-world utility will inevitably be constrained. No matter how advanced an AI algorithm is, it cannot be sustained in clinical practice if the input data remains disperse, unstructured, and disconnected from the hospital’s operational workflow.The CEO of a digital pathology company I recently interviewed similarly defined the starting point as workflow integration. It means that hospitals must first establish internal, functional baseline digital pathology capabilities before scaling up to AI-powered analytics and precision medicine.Global players are moving in the same direction. In May of this year, Roche signed a definitive agreement to acquire PathAI, a company specializing in digital pathology and AI-powered pathology technologies. The deal is valued at up to $1.05 billion, including upfront payments and bio-buck milestones. Rather than a transaction aimed purely at short-term revenue, this acquisition serves as clear evidence that pathology data and AI-based diagnostic capabilities are increasingly viewed as indispensable infrastructure for the era of precision medicine.Indeed, industry consensus holds that the value of pathology data will inevitably grow exponentially in the precision oncology and personalized medicine space. However, this transition will not happen automatically. Hospitals need clear financial incentives to invest in digital pathology, and pathology departments must be willing to adopt entirely new operational systems. Inter-system interoperability and data standardization are mandatory baselines. Furthermore, validation and accountability frameworks must be established to safely translate AI-generated insights into clinical care.To discuss the future of digital pathology, we must focus on Digital Transformation (DX) before AI Transformation (AX). Only when the pathology workflow shifts entirely to digital, data becomes standardized, and systems connect seamlessly with broader hospital networks can AI truly become the language of clinical practice. The starting point for pathology AI is not the algorithm, but the infrastructure.
- Company
- Reimbursement expansion for ‘Tevimbra’ gains momentum
- by Eo, Yun-Ho Jun 23, 2026 09:52am
- The cost-effective immuno-oncology therapy ‘Tevimbra’ is moving closer to a major expansion of National Health Insurance reimbursement in Korea.BeOne Medicines’ PD-1 inhibitor immunotherapy Tevimbra (tislelizumab) passed review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on June 4 and is currently awaiting a pricing negotiation order from the Ministry of Health and Welfare.The reimbursement expansion application includes 5 indications: ▲first-line combination therapy for unresectable, locally advanced, or metastatic esophageal cancer, ▲first-line combination therapy for unresectable or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma, ▲two first-line combination therapy indications in non-small cell lung cancer (NSCLC) and second-line monotherapy.Accordingly, whether BeOne Medicines, which has announced plans to offer a reasonable price, can reshape the immuno-oncology treatment landscape is gaining attention.Tevimbra’s successful reimbursement review represents more than the entry of another new drug. As reimbursement coverage for immunotherapies has recently expanded across multiple indications, growing pressure on National Health Insurance finances has emerged as a key challenge. In this environment, Tevimbra is considered a candidate capable of achieving cost savings through substitution within the same class.Claims spending on immunotherapies led by Keytruda (pembrolizumab) is currently estimated to be approaching KRW 1 trillion annually, with lung and gastric cancers accounting for more than half of that amount. If Tevimbra demonstrates a certain level of substitution effect in these indications, it is expected that the fiscal savings, starting at tens of billions of won, will further increase with its use.Although immunotherapies are among the most expensive drug categories, intensified competition within the same class could ultimately drive down pricing structures across the market.Tevimbra’s reimbursement strategy appears to follow a phased expansion approach. After first securing approval and reimbursement in the second-line esophageal cancer setting, an area with significant unmet need due to the lack of reimbursed immunotherapy options, the company is now seeking to expand into major indications such as lung and gastric cancers.Its clinical value is also well established. Tevimbra’s therapeutic position has already been validated through global treatment guidelines. Major guidelines, including those from the NCCN and ESMO, recommend Tevimbra as a treatment option on par with previously launched immunotherapies.In addition, its structural design, which inhibits Fcγ receptor binding and thereby minimizes T-cell depletion, provides a mechanistic differentiation that supports its potential as an ‘enhanced PD-1 inhibitor’ beyond merely being a substitute therapy.Also, Tevimbra obtained additional indications late last year in treatment settings where the use of existing immunotherapies remains limited, including perioperative treatment for NSCLC and nasopharyngeal carcinoma, and is expected to continue expanding its therapeutic indication.An industry source commented, “With fiscal discipline in health insurance becoming a priority, immunotherapies with strong cost-effectiveness are naturally more attractive from a policy standpoint. Tevimbra’s price competitiveness is expected to emerge as a meaningful factor in this landscape.”
- Company
- Finasteride 59%·dutasteride 61%...generics in the hair loss mkt
- by Chon, Seung-Hyun Jun 23, 2026 09:52am
- Generics are demonstrating dominance in the oral prescription hair loss treatment market. In the finasteride market, the market share of generics has surpassed the original brand, while in the dutasteride market, the generic share has surpassed 60%. Because of their low-price competitiveness, finasteride generics captured nearly 90% of the market share on a volume basis. Industry analysis anticipate that if the health authorities approve National Health Insurance (NHI) reimbursement to hair loss treatments, domestic pharmaceutical companies will benefit.According to data released by pharmaceutical market research firm IQVIA on June 23, sales of finasteride-based hair loss treatments reached KRW 21.4 billion in the first quarter of this year, a 3.0% year-over-year (YoY) increase. Organon Korea’s Propecia is the original 1mg finasteride formulation approved for the treatment of male alopecia in adult males aged 18 to 41. Proscar, which contains 5mg of finasteride, is indicated for benign prostatic hyperplasia (BPH).The finasteride hair loss treatment market has shown steady expansion, growing by 8.8% over the past three years from KRW 20.7 billion in Q1 2023. Quarterly sales trajectory of Propecia and generics (unit: KRW 100 million, source: IQVIA). BLUE: PROPESIA, GRAY: PROPESIA GENERICS, ORANGE LINE: Market share of generic products. AI-generated imageWithin the finasteride sector, generic products showed significantly higher growth rates compared to the original brand. In Q1, sales of the original Propecia amounted to KRW 8.7 billion, an 8.3% increase compared to the same period last year. However, this represents an 11.8% decline over a three-year period when compared to the KRW 9.9 billion recorded in Q1 2023. Propecia has been on a downward trajectory since peaking at KRW 10.2 billion in Q2 2023. Its Q1 revenue dropped by 14.6% relative to that Q2 2023.Meanwhile, Q1 revenue for Propecia generics amounted to KRW 12.6 billion, down 0.3% YoY. Although the quarterly growth rate of generics lagged behind the original brand this quarter, generic sales expanded by 17.5% over the past three years, from KRW 10.8 billion in Q1 2023. The revenue-based market share of generics in the finasteride hair loss market rose from 52.4% in Q1 2022 to 59.4% in Q1 of this year, climbing 7.0 percentage points over a four-year period.Quarterly market share of Propecia generic sales (unit: %, source: IQVIA). AI-generated imageBased on prescription volume, the dominance of generics becomes even more pronounced. In Q1, generics accounted for 88.2% of the total volume of finasteride hair loss treatments supplied. Due to their competitive pricing relative to the brand-name original, the volume-based market share significantly outpaced the revenue-based market share. The surge of generics was even more significant in the dutasteride market. GlaxoSmithKline's (GSK) Avodart is the original product in this market, indicated for the improvement of symptoms in benign prostatic hyperplasia (BPH) as well as the treatment of male pattern hair loss in adult males aged 18 to 50.In Q1, total sales in the dutasteride market reached KRW 27.4 billion, rising 12.9% YoY. Compared to the KRW 21.9 billion recorded in Q1 2023, the segment expanded by 24.9% over a three-year period, outpacing the growth rate of the finasteride market. In contrast to the overall market growth, the original Avodart generated KRW 10.4 billion in Q1, slipping 1.7% YoY. Avodart's growth has effectively stagnated, registering a 3.0% decline over three years from the KRW 10.7 billion recorded in Q1 2022.Conversely, generics to Avodart posted Q1 revenues of KRW 17.0 billion, surging 24.2% YoY. This marks an increase of 75.3% over a four-year period from the KRW 9.7 billion recorded in Q1 2022, demonstrating a steep upward trajectory. Quarterly sales trajectory of Avodart and generic (unit: KRW 100 million, source; IQVIA). GREEN: AVODART, BLUE: AVODART GENERICS, ORANGE LINE: Market share of generics. AI-generated imageThe revenue share of generics in the dutasteride market stood at 45.9% in Q1 2022, crossed the 50% threshold in Q1 2023, and advanced further to 61.0% in Q1 of this year. The expanding footprint of generics is attributed to aggressive market penetration by approximately 70 domestic pharmaceutical manufacturersIn Q1, the volume-based market share of dutasteride generics reached 68.0%, exceeding its revenue-based counterpart by 7.0 percentage points. This gap is analyzed as a direct result of entering the market with low-cost pricing advantages, driving up volume distribution. Among domestic companies, Hanall Biopharma demonstrated the most outstanding performance across both the finasteride and dutasteride generic markets. In Q1, Hanall Biopharma generated a combined revenue of KRW 6.2 billion from its Avodart generic, Adamo (KRW 5.4 billion), and its Propecia generic, Hair Gro (KRW 700 million).Other domestic companies, including Dongkoo Bio & Pharma, The U Pharmaceuticals, Dong-A ST, and Genuone Sciences, each recorded quarterly revenues exceeding KRW 1 billion in their respective Avodart and Propecia generic portfolios. Industry insiders anticipate that if hair loss treatments are officially listed for national health insurance reimbursement, high-share generic manufacturers will see a benefit in sales alongside the original brands.According to data on the "Supply Status of Hair Loss Treatment-related Medicines" submitted by the Health Insurance Review and Assessment Service (HIRA) to Rep. Kim Sunmin’s office (Rebuilding Korea Party), the total supply value of prescription-only hair loss treatments reached KRW 256.8 billion last year. Based on last year's supply data, if the patient co-payment rate for reimbursed hair loss treatments is set at 30%, it is estimated that the National Health Insurance fund would be responsible for an annual fiscal burden of approximately KRW 180 billion.
- Policy
- Hair loss drug reimbursement to cost ₩179.7B per year
- by Lee, Jeong-Hwan Jun 23, 2026 09:52am
- As the Ministry of Health and Welfare prepares to gather public opinion on extending National Health Insurance (NHI) coverage to hair loss treatments, the annual spending required for the coverage is estimated to be around KRW 128 billion to KRW 179.7 billion, depending on patients’ coinsurance rates.The estimate is based on a simple calculation using last year's supply value of prescription hair loss medications, assuming patient copayment rates of either 30% or 50%.The debate over whether to provide health insurance coverage for hair loss, which is not a life-threatening disease, is intensifying. In response, the Ministry of Health and Welfare intends to seek social consensus through a public policy forum jointly organized with the Ministry of the Interior and Safety.According to data on hair loss treatment drug supply submitted by the Health Insurance Review and Assessment Service (HIRA) to Rep. Sun-min Kim of the Rebuilding Korea Party, the value of hair loss medications requiring a physician's prescription increased from KRW 216.43 billion in 2022 to KRW 256.83 billion last year.Drug supply volume also rose substantially during the same period, from 295.74 million units in 2022 to 446.32 million units last year. As of April this year, 157.27 million units of the treatment, valued at KRW 86.46 billion, have already been supplied, maintaining a continued growth trend.The number of patients seeking medical treatment for hair loss continues to be in the hundreds of thousands range each year. According to claims data, the number of patients treated for alopecia was 250,573 in 2022, 247,382 in 2023, 241,217 in 2024, and 237,009 in 2025, remaining within a range of approximately 230,000 to 250,000 annually.As of April this year, 115,028 patients had already sought treatment. By gender, men accounted for 134,155 patients in 2025, compared with 102,854 women. However, women still represented approximately 43.4% of all patients, demonstrating that hair loss affects both sexes.By age group, individuals in their 20s through 40s, the core economically active population, accounted for more than half of all patients. In 2025, the most prescribed were patients in their 40s (53,489), followed by those in their 30s (50,712), 50s (46,539), and then 20s (35,803).By disease subtype, alopecia areata accounted for the majority of cases at 175,493 patients, followed by other non-scarring hair loss (noncicatricial alopecia, 29,583), androgenetic alopecia (23,941), and scarring alopecia (cicatricial alopecia, 11,779).Medical expenses paid to hospitals by patients are also on the rise. Total consultation costs for hair loss increased from KRW 36.70 billion in 2022 to KRW 39.28 billion last year.These figures include only physician consultation fees and diagnostic testing costs incurred at medical institutions and exclude prescription drug and dispensing costs.As a result, when combining patients’ medication expenses and medical treatment costs, annual spending on hair loss treatment exceeded KRW 290 billion last year.NHI burden depends on coinsurance rate…debate inevitableHealth and Welfare Minister Eun-kyeong Jeong has expressed plans to accelerate the implementation of insurance coverage for hair loss treatments as a follow-up measure to President Lee Jae-myung’s campaign pledge.However, the substantial financial implications have intensified debate over whether such coverage should be included within the National Health Insurance system. Discussion gained momentum after President Lee called for a review of insurance coverage for hair loss medications.If reimbursement is granted, the financial burden on the NHI system will vary according to the patient's coinsurance rate. Using the 2025 prescription drug supply value as a basis, a simple estimate suggests that if patients pay 30% of drug costs, the NHI system would bear approximately KRW 179.7 billion. If the copayment rate is set at 50%, the estimated annual financial burden would be approximately KRW 128.4 billion on the government’s part.Supporters of reimbursement argue that while hair loss is not life-threatening, it can significantly reduce quality of life and contribute to depression, social anxiety, and social withdrawal, making it a legitimate medical condition.They further contend that for young adults preparing for employment or marriage, treatment is not merely cosmetic but essential for social participation and daily functioning, and that the current out-of-pocket burden is excessively high because treatment remains non-reimbursed.Opponents, however, argue that the fundamental purpose of the National Health Insurance system is to protect citizens from severe and life-threatening illnesses. Using funds to address hair loss caused by aging or genetic factors, when the budget remains insufficient even for serious diseases such as cancer and cardiovascular disorders, could divert resources away from critically ill patients and ultimately result in higher insurance premiums for the public.
- Company
- Domestic DMFs lose ground despite pricing incentives
- by Kim, Jin-Gu Jun 23, 2026 09:52am
- Despite the government's efforts to encourage the use of domestically produced active pharmaceutical ingredients (APIs) through pricing incentives, the pharmaceutical industry remains largely unconvinced.The number of domestic Drug Master File (DMF) registrations in the first half of this year remained at a level similar to last year and fell below the half-year average recorded over the past 5 years, prompting criticism that more practical and effective policies are needed to promote API localization.According to the Ministry of Food and Drug Safety (MFDS) on June 22, a total of 434 new DMFs had been registered as of June 19 this year. Of those, only 22 were registered by companies located in South Korea. The figure includes only fully domestic APIs, for which the entire manufacturing process, from starting materials and intermediates to the final API, was carried out within Korea.This is similar to the 22 registrations recorded in the first half of last year and the 21 registrations in the second half of last year. However, compared with the average of 28.3 registrations per half-year over the past 5 years since the first half of 2021, the number has actually declined by 6 cases. Compared with 41 registrations recorded in each half of 2021, when the COVID-19 pandemic fueled calls for greater self-reliance of APIs, the current level is nearly half.The downward trend remains evident even when the scope is broadened to include partially domestic DMFs, in which at least one stage, from material, intermediate, to final API, is manufactured in Korea. The number of partially domestic DMFs in the first half of this year was 29, down 5 cases from 34 during the same period last year and about 6 below the 5-year half-year average of 36.6.When considering how the Ministry of Health and Welfare announced a pricing premium ‘up to 10 years’ under its pharmaceutical pricing reform for drugs using domestic APIs, this decline has drawn criticism that the system has little practical effect.The government had pledged substantial pricing incentives for products considered strategically important for strengthening domestic API self-sufficiency. While generic drug pricing rates are set to fall from 53.55% to 45% of the original drug’s price, premiums equivalent to 68% will be granted to ▲ supply-stabilization medicines produced using self-manufactured APIs, ▲national essential medicines using domestic APIs, and ▲ self-manufactured injectable antibiotics and pediatric medicines.Previously, such incentives applied only to newly listed products, but the revised policy will also apply retroactively to already listed products. For both essential medicines produced using domestic raw materials and those that utilize locally sourced API, the basic 10-year preferential pricing period will continue if additional requirements are met and the supply remains limited to three or fewer companies.Despite the prospect of reimbursement incentives lasting more than a decade, industry response has been lukewarm. Industry observers note that the government's pricing premium is insufficient to offset the overwhelming manufacturing cost gap compared with when using Chinese and Indian APIs.In fact, registrations of Chinese and Indian APIs surged to the second-highest level on record during the first half of this year.Of the 434 DMFs registered during the period, 381 originated from China or India, accounting for approximately 88% of the total. This is the second highest over the past 5 years, following a 90% share in the first half of last year. Chinese and Indian DMFs accounted for roughly 60% of registrations until 2022, exceeded 70% in 2023, and surpassed 80% in the first half of last year.Meanwhile, API supply diversification has deteriorated significantly. The share of APIs sourced from regions outside Korea, China, and India, such as North America, Europe, and Japan, had exceeded 30% as recently as the first half of 2022. However, the figure has steadily declined and now stands at just 7% in the first half of this year.An industry official criticized, “Considering labor costs, raw material procurement expenses, and environmental compliance costs, the production cost of domestic APIs is uncompetitive compared to those from China and India. The modest premium proposed by the government is nowhere near enough to provide pharmaceutical companies with an economic incentive to shift away from their existing China- and India-based API supply chains.”The official added, “The pricing reform still lacks clear subordinate regulations or guidelines regarding how the origin of starting materials and intermediates will be recognized. As a result, there is considerable confusion in the industry over exactly how much localization is required in order to qualify for preferential pricing.”
- Company
- Changes to TAVI reimb criteria… TAVI mkt intensifies
- by Hwang, byoung woo Jun 23, 2026 09:52am
- Patient access to aortic stenosis therapies is set to expand following a reform of South Korea's National Health Insurance reimbursement criteria for Transcatheter Aortic Valve Implantation (TAVI).Attention is turning to whether this criteria change will accelerate market growth, as the policy transitions from restricting reimbursement to patients aged 80 and older or those deemed inoperable to a system allowing the medical consensus of multidisciplinary Heart Teams. Transitioning from "patients aged 80" and "inoperable" to "clinical necessity"The Ministry of Health and Welfare (MOHW) has issued a revised administrative notice on 'Detailed Criteria and Methods for Applying Reimbursement' and effective June 22, reimbursement criteria for TAVI will undergo reform. The core reform shifts the criteria from "inoperable" to "clinical necessity," as adjudicated by institutional multidisciplinary Heart Teams.TAVI is a minimally invasive structural heart procedure that treats aortic stenosis by deploying a bioprosthetic valve via a catheter, eliminating the need for open-heart surgery. While initially targeted at elderly patients with high surgical risk, accumulating global clinical evidence has expanded its therapeutic indications to broader patient populations, both domestically and internationally. Previously, national health insurance reimbursement for TAVI was approved only for patients in high-risk categories with a Society of Thoracic Surgeons (STS) score exceeding 8%, those aged 80 or older, or cases where all cardiovascular thoracic surgeons on the institutional Heart Team explicitly signed off on the patient's surgical inoperability. The reform preserves the reimbursement criteria for high-risk surgical patients and individuals aged 80 and older. Crucially, however, it expands eligibility to include any patient for whom the entire multidisciplinary Heart Team agrees that a TAVI procedure is clinically necessary. This updates the regulatory method from a rigid system reliant solely on age or operability thresholds to a nuanced approach centered on patient-specific clinical needs. Consequently, this reform is highly likely to improve access for patients in their 70s, a cohort that previously fell into a regulatory blind spot. Under the old rules, septuagenarian patients seeking TAVI had to either incur an extraordinary out-of-pocket financial burden or navigate the high procedural barrier of securing an inoperable consensus from at least 2 cardiovascular thoracic surgeons.The operational mandates for institutional Heart Teams have also been streamlined to fit clinical realities. Previously, the system required at least two cardiovascular thoracic surgeons with over 5 years of post-fellowship cardiovascular surgical experience. The amendment now allows hospitals to meet this staffing requirement with a single surgeon with more than 10 years of experience in cardiovascular surgery. Furthermore, the mandatory in-person attendance requirement for anesthesiologists and radiologists has been changed to an "as-needed" consultation basis, with virtual video conferencing explicitly permitted in unavoidable circumstances. Another notable shift introduces a formalized re-deliberation mechanism: if the Heart Team fails to reach unanimous consensus initially, the team must engage in subsequent discussions to finalize an aligned therapeutic pathway. Professor Sung-jin Hong of the Department of Cardiology at Severance Hospital (insurance committee member for the Korean Society of Cardiology·the Korean Society of Interventional Cardiology) said, "This revision clarifies the decision-making architecture of the multidisciplinary Heart Team while realigning staffing criteria and operational rules with real-world settings. It will alleviate some of the procedural and personnel burdens that previously hindered practical clinical deployment."Improved patient access, emerges as a variable of market expansionThis reform of reimbursement criteria is likely to directly influence the structural heart market alongside expanding patient access. Broadening the criteria for reimbursed procedures allows patients who previously deferred treatment due to intense cost pressures or restrictive institutional thresholds to enter the reimbursed clinical pool. The prevalence of aortic stenosis has been accelerating rapidly alongside demographic aging. According to National Health Insurance data, the number of documented aortic stenosis (ICD-10: I35.0) patients escalated by approximately 56% over a four-year window, growing from 16,537 in 2020 to 25,826 in 2024. Within the same timeframe, ultra-elderly patients aged 80 and older surged by roughly 90%, from 6,283 to 11,944 individuals.Patients in their late 70s are regarded as the key market variable. While patients aged 80 and older already enjoyed robust therapeutic access within the existing coverage framework, the 70s cohort faced severe regulatory constraints despite being optimal clinical candidates for TAVI. By enabling reimbursement whenever the Heart Team establishes clinical utility, this reform is expected to resolve deferred procedural demand. Shifts are also anticipated at the institutional level. Lowering the minimum surgeon requirements and permitting remote participation will substantially reduce the operational burden of running a Heart Team. However, because TAVI is a highly complex intervention requiring advanced capital equipment, specialized hybrid theater setups, and extensive operator experience, the regulatory relaxation alone will not translate into an immediate, decentralized explosion of procedures across all community hospitals. The rationalization of procedural tariffs remains unresolved. Industry stakeholders have consistently noted that the current fee schedule does not adequately capture the intrinsic complexity and the intense multidisciplinary coordination of TAVI. Even with wider reimbursement boundaries, the velocity of real-world market expansion could remain constrained unless hospital fee margins and cost allocations are structurally improved.Despite this, the revision is widely evaluated as the critical regulatory inflection point for long-term category growth. Positioned at the intersection of a rising patient census, demographic aging, and a global trend toward expanded clinical indications, the relaxation of reimbursement rules is highly likely to enlarge the total addressable market. Edwards maintains market dominance as Medtronic chases afterWith anticipation over market expansion mounting, commercial competition among global medtech giants is garnering attention. According to industry sources, the domestic TAVI market is currently dominated by Edwards Lifesciences, which commands a majority share, pursued closely by Medtronic. Abbott and MicroPort also maintain active footholds as they attempt to scale their respective market shares. The reimbursement expansion is initially expected to play to the strengths of incumbent leader Edwards Lifesciences. Companies with deep clinical track records and established brand equity are historically best positioned to capture the immediate influx of newly unlocked demands.However, Medtronic is introducing aggressive competitive variables. This past March, Medtronic commercially launched its next-generation TAVI system, the Evolut FX+, in South Korea. The platform features an advanced design engineered to optimize future coronary access, facilitating subsequent percutaneous coronary interventions (PCI). This product strategy is interpreted as a strategy to target long-term survivors and younger patient demographics. As the TAVI target population changes from extreme-risk, elderly patients to a broader clinical demographic, competitive differentiators are evolving beyond immediate procedural success toward long-term post-procedural management and cross-departmental treatment access. Medtronic’s focus on a "lifetime management" framework for its new platform aligns directly with this shifting clinical trend. Professor Hong stated, "As we transition deeper into a super-aged society, the clinical need for TAVI will continue to intensify," and added, "Streamlining the multi-disciplinary decision-making process will provide clinical utility, ensuring patients receive optimal interventions without missing critical therapeutic windows." Professor Hong emphasized, "While this regulatory shift is a starting point, it must be followed by an established system to expand reimbursement scope, enabling patient access to appropriate care at the right time."
- Opinion
- "Cosentyx is shifting the treatment paradigm for hidradenitis suppurativa"
- by Son, Hyung Min Jun 22, 2026 09:23am
- "Previously, the therapeutic option for hidradenitis suppurativa was limited to systemic antibiotics and salvage surgical interventions. However, the introduction of advanced biological agent is shifting clinical goals."In a recent interview with DailyPharm, Professor Hee Jung Lee of the Department of Dermatology at Cha University Bundang Medical Center evaluated that the introduction of the interleukin-17A (IL-17A) inhibitor 'Cosentyx (secukinumab)' has opened new therapeutic opportunitiess for patients who are non-responsive to conventional standards of care.Professor Hee Jung Lee of the Department of Dermatology at Cha University Bundang Medical Center Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory skin disease characterized clinically by recurrent, deep-seated nodules, abscesses, fistulas (sinus tracts), and progressive fibrotic scarring. It occurs in inverse, high-friction anatomical zones such as the axillae, inguinal folds, and gluteal regions. Due to persistent purulent discharge, intense pain, and malodor, the disease imposes an extraordinary physical and psychosocial burden on patients.In its initial stages, HS frequently mimics acne vulgaris, folliculitis, or localized cutaneous infections, resulting in significant diagnostic delays. Global clinical literature indicates that patients experience an average diagnostic latency of 7 to 10 years. During this prolonged window, individuals routinely visit multiple medical departments or undergo repetitive, short-term incision and drainage (I&D) procedures without receiving a definitive diagnosis.The problem is that the consequence of delayed therapeutic intervention result in increased patient burden. While early-stage presentation is confined to transient inflammatory nodules, unmanaged disease progression triggers the formation of deep, interconnected subcutaneous sinus tracts and extensive, irreversible tissue distortion. In advanced stages, severe chronic pain compromises basic mobility, such as walking or sitting, and necessitates continuous complex wound care, profoundly impairing patients' professional and social functionality.Recently, treatment approaches have been shifting as more patients view HS as a systemic, immune-mediated chronic inflammatory disease. The updated European S2k Guidelines for Hidradenitis Suppurativa advocate for an integrated management matrix that delineates between inflammatory and non-inflammatory lesions. The guidelines emphasizes the importance of early intervention with biologics in moderate-to-severe cohorts to arrest disease activity before irreversible structural tissue damage occurs.Amid this shifting landscape, the IL-17A inhibitor Cosentyx is garnering significant attention. Marking the first novel biological mechanism introduced to the HS market in approximately 8 years, Cosentyx secured regulatory approval in South Korea in 2023, followed by the expansion of national health insurance reimbursement for severe adult HS late last year.Data from a recent domestic Medical Access Program (MAP) evaluating the real-world performance of secukinumab demonstrated that at week 16, Cosentyx recorded HiSCR achievement of 86.9%, IHS4-55 achievement of 78.3%, and NRS-30 (Skin Pain Reduction) of 81.8%, confirming significant treatment effects in real-world clinical landscape. HiSCR (Hidradenitis Suppurativa Clinical Response) is defined as a 50% reduction in abscess and inflammatory nodule count, with zero increase in abscesses or draining tunnels.Professor Kim said, "While clinicians previously faced limited treatment choices outside of antibiotic prescription or highly morbid surgeries, the commercialization of biologics is shifting the baseline expectations for severe HS management," and added, "Given that secukinumab confirmed its real-world efficacy within patient populations in South Korea, it is being established as a critical core therapy in clinical practice."Q. What is Hidradenitis Suppurativa (HS)?HS is classified as a rare chronic inflammatory dermatosis in Korea. Based on Health Insurance Review and Assessment Service (HIRA) data, approximately 12,000 patients were documented last year, though epidemiological prevalence studies estimate the baseline rate at 0.06% to 0.1%. This indicates a domestic patient number of roughly 30,000 to 40,000 individuals, suggesting a significant volume of undiagnosed cases. In the clinic, it is common to encounter patients who have endured unmanaged symptoms for 10 to 20 years.The disease manifests in areas where skin-on-skin friction occurs, such as armpits, groin and bottom. Clinical suspicion is warranted when painful, inflammatory lesions exceeding 1 cm recur at least twice within a six-month window. If active lesions are accompanied by palpable sinus tracts in these hallmark anatomical zones, a definitive diagnosis can be readily established.Recenty, disease awareness has risen substantially in recent periods. We are seeing increased self-referrals driven by high-profile public health disclosures, such as by singer Lee Hong-gi, and targeted medical education content across digital media.Q. Why is early, specialized dermatological intervention critical for this patient group?Due to the anatomical distribution of acute abscesses in the gluteal and inguinal areas, patients overwhelmingly present first to general surgery or colorectal clinics for emergent incision and drainage. Consequently, many individuals arrive in our dermatology departments exhibiting extensive, cross-hatched surgical scarring across the buttocks from dozens of historical operations. While acute drainage mitigates immediate pressure and pain, it fails to address the underlying immunological driver and degrades the patient's long-term quality of life.International clinical guidelines mandate an initial baseline course of targeted systemic combination antibiotics for at least 3 months. A pervasive challenge in real-world practice, however, is poor patient compliance; patients frequently discontinue the regimen after a single week once acute drainage subsides. Because HS is a deep-seated, chronic immunologic process, short-term antibiotic pulses are structurally ineffective. If a patient exhibits an inadequate response or therapeutic intolerance to first-line systemics, the protocol dictates an escalation to alternative systemics, subsequently changing to biologics or planned radical margin surgeries if control is not achieved.Q. How has the clinical introduction of secukinumab reshaped the advanced treatment matrix?While tumor necrosis factor-alpha (TNF-alpha) inhibitors previously represented the sole biological standard, a distinct subpopulation of patients either demonstrated primary or secondary nonresponse or had to discontinue therapy due to class-specific adverse events. The emergence of secukinumab, an IL-17A antagonist, has substantially diversified our advanced therapeutic options. Notably, IL-17 inhibitors have a robust, decade-long safety database across highly populated indications such as plaque psoriasis and psoriatic arthritis, which substantially lowers patients' psychological resistance to initiating advanced systemic therapy. While certain patients hesitate to initiate traditional TNF-alpha blockers due to class warnings regarding systemic malignancies, including cutaneous cancers, or complex immunogenicity profiles, IL-17A inhibition provides a highly reassuring, differentiated safety profile that enhances clinical onboarding.Q. What was the background for conducting clinical studies in South Korea, and what were the most significant result?Domestic HS phenotypes differ from the global clinical, necessitating localized validation. Globally, HS exhibits a strong female predominance. However, in South Korea, males comprise approximately 75% of the patient population. Furthermore, while Western cohorts present predominantly with axillary and inguinal involvement, domestic patients present with a distinct predilection for severe gluteal disease. This epidemiological divergence is hypothesized to stem from lower baseline obesity rates in Korea alongside distinct genetic variances.In the domestic MAP analysis, secukinumab delivered exceptionally robust outcomes, with specific response metrics trending higher than those documented in the global Phase III program. The clinical significance lies in the holistic efficacy demonstrated across multiple concurrent endpoints, including HiSCR, IHS4-55, and objective pain reduction (NRS-30). Furthermore, concurrent transcriptomic analyses verified that key upstream pro-inflammatory pathways were directly down-regulated at the molecular level post-treatment, correlating perfectly with clinical resolution.Q. Following the health insurance reimbursement for secukinumab, what are the cases regarding patient quality of life in real-world clinical practice?The secukinumab reimbursement has created new treatment options for patients who previously failed TNF-alpha inhibition or had no options due to tolerability issues. It has also optimized the treatment pathway for transitional age groups; young patients who spent years unable to access advanced biological interventions due to regulatory constraints can now safely initiate a highly selective IL-17A inhibitor immediately upon turning 18.We have observed multiple cases of improved patient quality of life in real-world clinical practices. Generally, a therapeutic intervention is deemed successful if it achieves 50% symptom reduction. At the 4-month clinical evaluation checkpoint, our center recorded a 0% discontinuation rate due to lack of efficacy, underscoring high patient retention and satisfaction.Q. With the emergence of a biological agent, can we project a "cure" for HS?The domestic regulatory framework for the Specialized Copayment Exemption Program was recently updated. Previously, the system strictly limited registration to end-stage patients exhibiting extensive, irreversible fibrotic scarring or massive structural distortion. The revised criteria now capture patients presenting with high-intensity, active inflammatory burdens, enabling significantly earlier access to biologics. Consequently, we are documenting clinical cases where high-inflammation patients achieve complete clinical clearance of all active lesions.However, for advanced patients who already present with extensive, irreversible structural tissue architecture destruction, a complete cure remains clinically unrealistic. In these severe cohorts, stabilizing the disease to achieve a sustained 50% reduction in inflammatory lesions and restoring basic daily function represent a major therapeutic victory. Managing these structural challenges continuously reinforces the pharmaceutical and clinical imperative for early, aggressive biologic intervention.Q. Regarding the system, which areas need improvement?There are two points. First, expanding therapeutic access for pediatric and adolescent cohorts. While early intervention is universally recognized as vital to prevent irreversible tracking, a severe therapeutic gap persists for teenage patients due to a lack of local pediatric indications. The US FDA proactively expanded the label for this agent to include adolescent HS patients by bridging established safety data from other pediatric indications, despite the absence of an HS-specific adolescent trial. Conversely, domestic teenage patients are forced to cycle through repetitive, sub-optimal antibiotic courses and painful surgical drainages, effectively waiting until they turn 18 to qualify for biological therapies.Second, the restructuring of the surgical system. Advanced, recalcitrant HS demands highly complex, wide-margin radical excisions coupled with complex reconstructive flap surgeries. However, the current national medical fee rate fails to accurately compensate for the technical complexity and the significant resource allocation required for these specialized procedures. Establishing distinct criteria is imperative for patients to receive necessary treatments.
