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- 2026-07-22 03:12:16
- 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.
- 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.
- Policy
- ’Social consensus is key’ to hair loss drug reimb in Korea
- by Lee, Jeong-Hwan Jun 22, 2026 09:22am
- MOHW Director Jung-Min YooDiscussions on expanding National Health Insurance (NHI) reimbursement coverage for hair loss treatments are expected to gain momentum, following Health and Welfare Minister Eun-kyeong Jeong’s announcement of the public collection of opinion on reimbursment for hair loss medications, one of President Jae-myung Lee’s campaign pledges, as a major policy priority in the second half of this year.The Ministry of Health and Welfare (MOHW) appears to have already established much of the practical framework for various scenarios, including eligibility criteria, reimbursement methods, and financing, so that the policy can be implemented immediately without administrative delays once a social consensus is reached.Jung-min Yoo, Director of the MOHW’s Insurance Benefits Division, recently outlined the ministry’s preparations and future plans regarding insurance coverage for hair loss medications during a meeting with healthcare reporters.Following Minister Jung’s announcement that the government will gather public opinion on the issue, the citizen-participation forum ‘Everyone’s Forum,’ hosted by the Ministry of the Interior and Safety on July 4, is expected to be a critical turning point in determining whether insurance coverage for hair-loss treatments will be available.“Hair loss is not merely a cosmetic issue, but a disease”… Focus on intergenerational equity in insurance contributionsThe discussion is rooted in President Lee’s comments regarding “intergenerational equity in health insurance contributions” and the recognition of hair loss as a medical condition.Yoo said, “The perceived benefits of health insurance reimbursement differ among social classes. Hair loss is not purely a cosmetic concern. It has a diagnostic disease code, and dermatology societies already have assessment tools to evaluate disease severity.”Due to its clear disease characteristics, the ministry intends to determine whether the public insurance budget should be allocated to hair loss based on the outcome of broader social discussions.Yoo emphasized, “We have set up simulations so that regardless of the direction of public consensus, the ministry’s internal reviews do not become a source of delay. We have already reviewed multiple options and financial scenarios so that the policy can be launched immediately once the reimbursement scope and coverage method are determined.”Biggest issue lies in ‘eligibility and criteria’…”Practical review already completed”Some healthcare experts have argued that the greatest challenge in reimbursing hair loss treatments would be in ‘defining eligible patients and reimbursement criteria.’ Even if public demand exists, determining patient coinsurance levels and treatment scope remains a complex task.In response, Yoo cited the example of ‘dental implant reimbursement,’ which was initially limited to individuals aged 65 and older. Yoo explained that a direction has been set for its reimbursement after extensive discussions with academic societies under President Lee’s direction last December.Yoo said, “Androgenetic alopecia has an established disease code, and academic societies possess age-specific prevalence data. Drug prices have declined significantly compared with when the campaign pledge was first announced, and some hair loss medications are already reimbursed for prostate disease treatment. We have considered these factors comprehensively and completed the practical groundwork.”Public forum to engage without a fixed budget cap… key issue will be manufacturers’ reimbursement applicationsThe ministry does not plan to predetermine the budget by setting an upper limit such as “within KRW 1 trillion.” Instead, it intends to consider all possibilities.Based on pre- and post-forum surveys and in-depth discussions conducted during the July forum, the government plans to assess public consensus and then determine the final scope of coverage and funding.However, gaining active participation from pharmaceutical companies will also be an important task. While the government can directly decide reimbursement for medical procedures, drug reimbursement requires manufacturers to submit applications for listing and propose an appropriate reimbursement ceiling price before reimbursement evaluations can even begin.Yoo said, “Procedural requirements cannot be skipped. However, if public opinion favors swift implementation, there will be no delays on MOHW’s part during subsequent stages, including division-level discussions and deliberations by the Health Insurance Policy Deliberation Committee once manufacturers submit their applications.”
- Policy
- Concerns mounting over RWE for cutting reimb
- by Jung, Heung-Jun Jun 22, 2026 09:22am
- The Ministry of Health and Welfare (MOHW) announced that while it aims to accelerate patient access to critical therapies through its expedited listing pathway, subsequent fiscal management via reimbursement adjustments based on post-marketing evaluations remains unavoidable.Addressing pharmaceutical industry anxieties regarding data limitations in Real-World Evidence (RWE)-driven post-listing price adjustments, the MOHW emphasized that "fiscal management is a core responsibility of the government."The MOHW noted that while expanding patient access to breakthrough treatments is vital, managing the national health insurance budget is an equally binding statutory duty, thereby underscoring the necessity of adjusting reimbursement during post-evaluation.During an RWE symposium hosted by the Health Insurance Review and Assessment Service (HIRA) at the aT Center on June 19, industry representatives proposed leveraging RWE to refine patient sub-populations rather than to enforce outright reimbursement cuts.They explained that pharmacoeconomic evaluations utilizing RWE face inherent limitations regarding data reliability, making them sub-optimal for driving definitive pricing and coverage adjustments.Park Seon-eun, coordinator at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), stated, "We fully align with the policy direction of prioritizing patient access to therapy first and subsequently accumulating additional clinical evidence from real-world practice. However, the industry harbors significant concerns regarding the prospect of utilizing accumulated RWE for ex-post pharmacoeconomic evaluations to recalculate drug prices."Park emphasized, "RWE has significant value in identifying which specific patient subgroups derive the greatest clinical benefit, thereby allowing for a more sophisticated delineation of eligible reimbursement criteria."Park further pointed out international precedents, noting that even in Europe, multiple attempts have been made to execute economic evaluations utilizing national registries, but decision-makers frequently failed to utilize the data due to fundamental gaps in data reliability."Re-calculating the prices of novel therapies using RWE collected to resolve initial clinical uncertainty risks chilling the core legislative intent and policy objective of the expedited listing framework, which is to expand patient access," Park expressed concerns.Conversely, the MOHW stated that utilizing RWE for reimbursement adjustments under the expedited listing and post-evaluation scheme is unavoidable, though it conceded the necessity of establishing clear frameworks to ensure the transparency and credibility of RWE methodologies.The MOHW explained that post-marketing evaluations leveraging RWE possess clear advantages, such as ▲reflecting unique domestic patient phenotypes ▲capturing local clinical environments ▲validating long-term therapeutic outcomes.Lee Eun-joo, a section chief from the Pharmaceutical Benefits Division at the MOHW, stated, "Once a drug enters the expedited listing track, the evaluative paradigm shifts toward confirming whether the actual clinical value justifies the continuous infusion of health insurance funds. RWE will serve as the foundational data for executing these post-marketing evaluations and act as a critical performance indicator for real-world outcomes."Lee added, "The government maintains a firm commitment to reducing structural delays that compromise patient access to therapies for rare and severe diseases when treatments exist. However, simultaneously, the government has an obligation to fulfill its role and responsibility in fiscal management, given that the National Health Insurance system is funded by the public."Representatives from patient advocacy groups participating in the panel discussion highlighted the critical importance of upfront contracts to prevent friction during post-evaluation coverage adjustments.Ahn Sang-ho, representative of the Korea Congenital Heart Disease Patient Association, said, "To prevent these concerns from turning into reality, we must establish a structural framework where evaluation commences concurrently with the listing," and added, "Data collection methodologies, post-evaluation price reductions, refund rate adjustments, and modifications to reimbursement criteria must be codified as pre-contractual conditions. We can mitigate conflicts and safeguard the national health insurance budget through this method."
- Policy
- Accelerated listing reshapes RWD evaluation
- by Jung, Heung-Jun Jun 22, 2026 09:22am
- Regulations governing full-cycle management using real-world data (RWD) are expected to be strengthened as part of the pilot program for expedited listing of rare disease treatments.Because a new framework linking evaluation outcomes to reimbursement adjustments will be established, the Health Insurance Review and Assessment Service (HIRA) plans to gather stakeholder feedback and incorporate related standards and procedures into its internal regulations.On June 19, HIRA held a symposium on real-world evidence (RWE) at the Yangjae AT Center, presenting a roadmap for enhancing the substance of pharmaceutical benefit evaluations.During the event, Ra-won Kang, Head of Health Insurance Reimbursement and Assessment Service’s Rare and Severe Disease Performance Assessment Department, reviewed the current status of pharmaceutical performance assessment and emphasized the need for changes resulting from the accelerated-listing/post-evaluation pilot program.At present, pharmaceutical performance assessments are conducted for risk-sharing agreement (RSA) drugs that lack evidence and require RWD collection.There are two main types of pharmaceutical performance assessments. One is the ‘performance-based refund type,’ under which a manufacturer provides refunds at a predetermined rate if treatment outcomes fail to meet agreed targets for individual patients. The other is the ‘drug-level outcomes evaluation type,’ in which reimbursement is granted on the condition that additional evidence is generated. From 2022 through June 2026, HIRA conducted performance evaluations on a total of 32 drugs.However, because the basis and mechanisms for reimbursement adjustments following data collection have remained unclear, there have been limitations in translating evaluation results into actual reimbursement adjustments.Kang explained, “Performance-based risk-sharing arrangements are reaching a turning point. The 5-year risk-sharing agreements for Kymriah and Zolgensma will expire next year, meaning their re-evaluation period is approaching. At the same time, the expedited listing for rare disease treatments will be implemented in earnest. A system is being established to reflect accumulated evidence in post-listing evaluations, and registries centered on eligible drugs will be prepared.”With the need for pharmaceutical benefit assessment using Real-World Data (RWD) rising, Kang explained that the system itself must be strengthened. This includes establishing plans in advance for how evaluation results will be utilized, disclosing evaluation outcomes, and clearly defining standards and procedures for linking those results to reimbursement adjustments.Furthermore, regarding performance assessment, Kang noted that areas including ▲insufficient feedback following post-listing evaluations, ▲increased burden of generating evidence, ▲patient access to treatment, and ▲governance and decision-making required improvement.Kang said, 'Management is necessary to prevent delays in new drug listing, and safeguard plans must be established so that patients already receiving treatment do not face discontinuation, even when the assessment results are unfavorable.'"Full-cycle management is necessary. We are reviewing tasks to standardize the methodology for listing, data collection, monitoring, assessment, disclosure of results, and feedback. Once a draft is prepared, we will seek stakeholder input and refine it into a reasonable framework.”Kang also emphasized, 'If the public sector takes the lead in building a platform with the participation of the medical and industrial sectors, data can be utilized in various ways to generate value. For the generation and utilization of RWD, collaboration among institutions and governance structures involving relevant stakeholders will be necessary.”
- Policy
- Olumiant reimbursed for severe alopecia next month
- by Jung, Heung-Jun Jun 21, 2026 02:49pm
- The government will establish new reimbursement criteria to cover treatments of severe alopecia areata in adults. In addition, reimbursement coverage for Korea's 37th domestically developed new drug, Zaquovo (zastaprazan), will be expanded to include the gastric ulcer indication.On June 18, the Ministry of Health and Welfare (MOHW) made an administrative notice regarding its proposed revisions to the "Detailed Standards for the Application and Methods of National Health Insurance Benefits." The revised standards are scheduled to take effect on July 1.Reimbursment for Eil Lilly Korea’s JAK inhibitor Olumiant (baricitinib) will be expanded to cover adults with severe alopecia areata.To qualify, patients must have received conventional therapies such as systemic corticosteroids or cyclosporine for at least three months without achieving a reduction of 30% or more in the Severity of Alopecia Tool (SALT) score, or must be unable to continue treatment due to adverse effects.In addition, reimbursement will apply only to patients who either have a ▲SALT score of 50 or higher or a ▲SALT score between 20 and 50 accompanied by complete loss or clearly visible interruption of both eyebrows and eyelashes.Meanwhile, Onconic Therapeutics' Zaquovo is expected to broaden its prescribing scope through reimbursement expansion for gastric ulcer treatment, following its existing coverage for erosive gastroesophageal reflux disease (GERD).The expansion comes one year after the drug received regulatory approval for the gastric ulcer indication in June of last year. Among P-CAB therapies, Zaquovo became the second product to obtain a gastric ulcer indication in Korea.In addition, 29 products including Chong Kun Dang's third-generation epilepsy treatment Briveta Tab (brivaracetam), will be newly listed for reimbursement next month. Notably, they will gain reimbursement coverage before UCB Korea’s original product, Briviact.Epilepsy drugs from 7 pharmaceutical companies will be listed simultaneously, which includes Daewoong Pharmaceutical's Brivatop Tab, Bukwang Pharmaceutical's Brivafil Tab, Whanin Pharm’s Briva Tab, Samjin Pharmaceutical's Bricetam Tab, Myung In Pharm’s Buripam Tab, and Hyundai Pharm's Brilact Tab, in addition to Chong Kun Dang's Briveta Tab.Patients whose seizures are not adequately controlled at the maximum dose of monotherapy or when dose escalation is limited by adverse effects may consider combination therapy with agents of different mechanisms. Up to four concomitant antiepileptic drugs will be reimbursed for patients with refractory epilepsy and similar conditions. Prescribers must submit a treatment justification report if more than four agents are used concurrently.The reimbursement criteria for dry eye syndrome therapies will also be revised following the reimbursement listing of Cyspol Ophthalmic Solution from Unimed Pharm next month. Polyethylene glycol 400 plus propylene glycol has been added to the list of tear substitute agents among single-use artificial tear products.In addition, reimbursement rules for long-term prescribing of GSK Korea's severe asthma drug Nucala (mepolizumab) and the Nucala Autoinjector will be tightened to align with standards applied to other biologic therapies. Following hospital discharge, outpatient prescriptions will be limited to a maximum of 4 weeks. For patients who remain free of adverse effects after 6 months of treatment, the reimbursable long-term prescription period will be reduced to a maximum of 8–12 weeks, approximately half of the previous allowance.
- Policy
- Drug pricing reform faces public interest audit petition
- by Jung, Heung-Jun Jun 18, 2026 03:35pm
- The Ministry of Health and Welfare's (MOHW) proposed drug pricing reform has run into an unexpected hurdle, a public interest audit request. Regardless of whether the Board of Audit and Inspection (BAI) chooses to formally accept the request, administrative and procedural conflict is expected in the regulatory overhaul.The Association of Pharmacists is filing a formal public interest audit request with the BAI today (June 17th) targeting the core provisions of the pricing reform. The association previously initiated a similar audit against the MOHW and the Health Insurance Review and Assessment Service (HIRA) in 2019, surrounding the controversial reimbursement re-evaluation of choline alfoscerate.Under current statutory guidelines, a public interest audit can be requested by civic organizations possessing more than 300 members, provided there are reasonable grounds to suspect that an administrative action by a public entity compromises the broader public interest. The Association of Pharmacists is filing a formal public interest audit request with the Board of Audit and Inspection (BAI) on June 17. AI-generated imageThe Association of Pharmacists is scheduled to officially submit the petition to the audit bureau on the morning of June 17th. The central premise of their challenge is that, while the revised pricing policies will heavily inflate national health insurance expenditures, the ministry entirely bypassed mandatory regulatory verification procedures, including the preliminary feasibility studies prescribed under the National Finance Act.The audit petition primarily focus on clauses projected to drive up healthcare spending, including ▲preferential pricing policies for generic medications ▲ fast-track expedited listing pathways ▲upward adjustments to the Incremental Cost-Effectiveness Ratio (ICER) thresholds ▲flexible drug pricing contract systems. The group deliberately curated its petition to isolate elements deemed most detrimental to the long-term fiscal sustainability of the national insurance fund. "While certain generic price reductions will be carried out, our internal assessment suggests those savings remain capped at a few hundred billion KRW, whereas measures like fast-track listings and elevated ICER ceilings will increase the net financial burden," stated Lee Dong-geun, Vice Chairman of the association. Criticizing the lack of robust economic impact assessments, Lee added, "If a policy demands vast additional public expenditure, it is imperative to rigorously simulate and disclose the cost-benefit dynamics before implementation." The association noted that despite persistent warnings regarding these structural vulnerabilities, the health ministry has consistently stonewalled industry feedback and pushed forward with the execution of the policy package.Currently, the MOHW is implementing pricing reform through a phased reduction. A draft revision of the "Criteria for Determination and Adjustment of Pharmaceutical Benefits," which includes explicit price premiums for designated "innovative" and "semi-innovative" pharmaceutical firms, is currently undergoing an administrative notice window to gather public and industry comments through July 13th.Furthermore, the Health Insurance Policy Review Committee resolved during its March session to stagger implementation dates, scheduling the upward expansion of the ICER threshold for 2027 and the implementation of fast-track drug registration systems for 2028. The expedited listing mechanism for orphan drugs treating rare diseases will be launched via an initial pilot framework before expanding to broader therapeutic categories."Because the MOHW’s unilateral policy decisions and administrative procedures currently lack formal regulatory checks and balances, an official audit request was our sole mechanism to force structural oversight," Lee emphasized. Lee asserted that any structural flaws identified within the currently noticed administrative texts must be corrected before final promulgation. Although the probability of the BAI fully accepting the public interest audit remains modest, the audit petition succeeds in turning public focus toward fiscal exposure, establishing an enduring pressure point for the health ministry as it continues the pricing modifications.
- Policy
- Rush to apply for generic marketing authorization…"indication splitting"
- by Lee, Tak-Sun Jun 17, 2026 04:31pm
- AbbVies Rinvoq Extended-Release tabletsKorean pharmaceutical companies are splitting implications to launch generics of AbbVie Korea’s blockbuster autoimmune treatment, Rinvoq (upadacitinib) Extended-Release tablets. This strategy is to partially neutralize the extended enforcement period of the original brand's core patent for its substance. If this strategy succeeds, the launch timeline for these generic versions could be accelerated by two years, from May 2032 to December 2030. According to industry sources on June 15, multiple pharmaceutical companies submitted marketing authorization applications for upadacitinib formulations to the Ministry of Food and Drug Safety (MFDS) on June 4. The filings were scheduled on the immediate day following the June 3 expiration of Rinvoq’s data protection (re-examination) window.According to the tracking data disclosed by the MFDS, unlike the multi-indicated original brand, these developers applied for marketing authorization of three indications: ▲atopic dermatitis ▲ulcerative colitis ▲Crohn's disease. This strategy directly aligns with the legal rationale underpinning ongoing patent trials challenging the extension of the substance patent duration. By narrowing their focus to the highly marketable fields of atopic dermatitis and inflammatory bowel disease (IBD), the generic companies intend to challenge the unextended patent window.If the generic companies secure a favorable final ruling on their patent circumvention claims, they would launch their products as early as December 1, 2030. This move would bring the market entry timeline forward by approximately 18 months ahead of the extended substance patent’s expiration date in May 2032.In March of this year, the Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of 16 domestic pharmaceutical companies, including Daewoong Pharmaceutical, Samjin Pharmaceutical, Chong Kun Dang, Huons, Dong-A ST, Ildong Pharmaceutical, and GC Biopharma, in a negative scope-of-confirmation trial targeting Rinvoq's crystalline form patent, which is set to expire on October 17, 2036.These companies had previously filed their initial trial petitions between August 19 and September 2 of last year, successfully satisfying a key administrative prerequisite to secure Priority Marketing Authorization rights. Consequently, the most prolonged patent wall blocking market entry until 2036 has been dismantled. After that, the challenge shifted to the primary substance patent, which is protected through May 16, 2032. Initiated by Dongkoo Bio & Pharma, as well as 12 other companies, including Daewoong Pharmaceutical and Samjin Pharmaceutical, filed trial petitions between April 30 and May 14 to contest the regulatory extension of the substance patent's term.This strategy aims for an "indication splitting". While Rinvoq currently has six approved clinical indications, including rheumatoid arthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease, the generic companies argue that although the originator secured a term extension due to regulatory review delays, the enforcement of this extension should apply exclusively to rheumatoid arthritis, the target indication of the initial clinical trials. If this succeeds, generics could lawfully launch for the remaining indications immediately following December 1, 2030, which marks the baseline expiration date of the substance patent before its regulatory extension. In addition to legal debate, companies are filing applications for marketing authorization.A pharmaceutical industry insider said, "Now, the strategy of domestic firms to select highly competitive indications like atopic dermatitis and IBD for an expedited commercial launch is being realized rapidly," and added, "MFDS's approval and IPTAB’s upcoming rulings on the substance patent extension will serve as a market shifter, shifting the competitive landscape of the domestic autoimmune market."According to UBIST data, Rinvoq generated approximately KRW 36.2 billion in domestic outpatient prescription sales last year.
- Policy
- RET-targeted Retevmo re-enters price negotiations after 3yrs
- by Jung, Heung-Jun Jun 17, 2026 04:31pm
- Eli Lilly Korea's RET-targeted cancer therapy ‘Retevmo (selpercatinib)’ has entered reimbursement price negotiations for the second time since 2023.Approximately 5 years after becoming the first RET-targeted therapy approved in Korea, the drug is now closer than ever to securing reimbursement coverage.According to industry sources on the 15th, Retevmo, which recently received a positive reimbursement recommendation from the Drug Reimbursement Evaluation Committee (DREC), immediately entered price negotiations with the National Health Insurance Service (NHIS).The DREC recognized Retevmo’s reimbursement as adequate for ▲locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and ▲advanced or metastatic RET-mutant medullary thyroid cancer that requires systemic therapy.Abnormal activation of the RET gene, such as through fusion mutations in receptor tyrosine kinase involved in cell development, can lead to cancer.Following the withdrawal of Roche Korea's Gavreto (pralsetinib) from the Korean market, Retevmo is currently the only RET-targeted therapy available in Korea. However, despite receiving regulatory approval nearly 5 years ago, the drug has remained available only through non-reimbursed prescriptions, leading patients to repeatedly raise concerns over the high out-of-pocket cost.Last year, public interest intensified when a national petition calling for expedited reimbursement listing surpassed 50,000 signatures.Lilly has pursued reimbursement for Retevmo three times since obtaining approval. In 2022, reimbursement criteria were established following two reviews by the Cancer Disease Deliberation Committee (CDDC), and the drug subsequently passed the DREC in 2023. However, reimbursement efforts stalled when price negotiations with the NHIS collapsed later that year.A gap of over a year and a half followed, during which patient advocacy efforts calling for rapid reimbursement continued.Lilly resubmitted its reimbursement application in April of last year. Unlike previous submissions, the new application included Phase III clinical data and strengthened pharmacoeconomic evidence. The company ultimately cleared DREC review once again and has now entered a second round of NHIS price negotiations.Given the absence of alternative RET-targeted therapies and the improved pharmacoeconomic evaluation data, industry observers believe Retevmo is significantly closer to reimbursement approval than in previous attempts. However, the final outcome is expected to depend largely on negotiations surrounding the Risk-Sharing Agreement (RSA) type and implementation.
- Policy
- Sanofi's 'Nexviazyme' for Pompe disease in shortage
- by Lee, Tak-Sun Jun 17, 2026 04:31pm
- Product photo of NexviazymeFollowing concerns about a supply shortage of Sanofi-Aventis Korea’s orphan drug 'Nexviazyme (avalglucosidase alfa)', South Korean health authorities have initiated a review to support it. Given that this drug is an essential medicine with no alternative, health authorities aim to preemptively address clinical gaps for patients.Sanofi-Aventis Korea officially announced the supply deficit of Nexviazyme to the Ministry of Food and Drug Safety (MFDS) on June 12.The company attributed supply shortage to "global manufacturing capacity deficits relative to rising international demand, as well as by shipping and logistics delays stemming from geopolitical conflicts in transit regions through the Middle East."Nexviazyme is an enzyme replacement therapy (ERT) indicated for patients diagnosed with Pompe disease, a rare hereditary metabolic disorder. Pompe disease is a condition caused by a deficiency of the enzyme required to break down glycogen, leading to abnormal intracellular accumulation of glycogen in muscle tissue. This condition triggers progressive systemic skeletal muscle atrophy, loss of ambulation, and respiratory insufficiency, which can lead to mortality in severe clinical cases. Notably, Nexviazyme is the latest medicine with enhanced cellular drug uptake compared to existing standard-of-care agents, thereby demonstrating clinically meaningful improvements in patients' respiratory parameters and ambulatory functions. In South Korea, it is categorized as an irreplaceable essential medication with no therapeutic alternatives available in the market. Sanofi reported concerns through its shortage notification, stating that "Regular monthly supply and strict adherence to the dosing regimen are ncessary for this product. Any supply disruption could expose patients to a rapid, quantitative decline in their six-minute walk test (6MWT) scores, a prognostic indicator," and added, "Enzyme deficiencies in active myocytes trigger irreversible skeletal muscle damage and atrophy, which directly correlate with deterioration in overall clinical status and the loss of autonomy in activities of daily living."Currently, Sanofi Korea has activated an emergency import protocol. Although the company expedited an import of 1,200 vials on June 12, this volume remains insufficient to satisfy regional demand, leaving the drug vulnerable to an early out-of-stock (OOS) scenario. Consequently, while Sanofi Korea plans to import an additional 1,700 vials by July 20, it is concurrently exploring regulatory channels to directly introduce foreign-labeled packaging (global packs) to bridge the temporary inventory gap.The MFDS has begun assessing the current situation and implement administrative support measures to protect patient access. An MFDS official stated, "While the Middle Eastern war may not seem a direct contributing factor, avoiding a therapeutic gap remains the MFDS's top priority," and added, "Based on feedback from the manufacturer, the MFDS is actively considering administrative fast-tracking, including granting exemptions from localized Korean labeling requirements for imported product lots originally destined for other countries to facilitate expedited customs clearance.Nexviazyme has been covered under the National Health Insurance system since September 1, 2023. It requires an intravenous infusion of 20 mg per kilogram of body weight every two weeks; a patient weighing 60 kg requires a 1,200 mg dose. With the insurance price set at KRW 1,436,600 per 100-mg vial, bi-weekly treatment costs reach KRW 17.16 million. However, because eligible individuals qualify for the rare disease copayment exemption program, patients are responsible for only 10% of the total treatment cost out of pocket.
