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- 2026-07-22 03:12:16
- Policy
- Minister Jeong Eun-kyeong, alopecia reimb·convenience store OTC discussions
- by Lee, Jeong-Hwan Jun 16, 2026 08:33am
- Attention is drawn to the Ministry of Health and Welfare (MOHW) as Minister Jeong Eun-kyeong announces a policy push on previously postponed healthcare agendas, marking the first anniversary of the current administration. Minister Jeong has unveiled key strategic priorities for the second half of the year.Industry analysis suggests that the policy push on highly contentious regulatory issues represents a strategic measure by Minister Jeong to avoid criticisms regarding a perceived deficit in impactful policy performance occasionally raised within political circles and the presidential office.On June 14, Minister Jeong brought major industry discussions by incorporating high-stakes agendas to the forefront of the ministry’s second-half project, explicitly outlining plans to expand national health insurance reimbursement for ▲alopecia treatments ▲broaden the retail formulary for over-the-counter (OTC) drugs in convenience stores ▲scale up home delivery frameworks for prescription medications under the non-face-to-face treatment system. Notably, attention is drawn to the expansion of National Health Insurance coverage for anti-alopecia therapeutics, a high-profile campaign pledge championed by President Lee Jae Myung that previously triggered intense public discourse.President Lee had previously committed to the reimbursement expansion by addressing the discomfort by the younger male demographic, arguing that alopecia extends far beyond aesthetic concerns to induce depression, social anxiety, and diminished self-esteem, thereby qualifying it as a clinically treatable condition impacting foundational health.However, the MOHW maintained a neutral stance amid fierce counterarguments questioning the fiscal rationale for subsidizing alopecia treatments, given that finite state reimbursement reserves are chronically underfunded to cover high-priority oncology and orphan drugs for rare, intractable diseases. Minister Jeong announced that the MOH and the Ministry of the Interior and Safety will host the inaugural 'Public Deliberation Forum' on July 4 to examine the integration of alopecia drugs into the health insurance system.This forum represents an official public consultation process. Expert presentations will precede extensive citizen-led focus panels to gauge broader societal consensus. Minister Jeong confirmed that "internal financial impact assessments evaluated the required fiscal expenditures from the national health insurance budget have already been completed. "Government insiders interpret this aggressive signaling as a calculated alignment with the presidential office, elevating the execution of key campaign pledges to the top of the second-half ministerial project to showcase decisive executive momentum.Furthermore, Minister Jeong addressed both convenience-store OTC drug availability and remote prescription delivery initiatives, two highly volatile portfolios in which the MOHW had maintained a cautious approach amid heavy pushback from influential pharmacist advocacy groups. For retail OTC drug distribution, Minister Jeong explicitly committed to a second-half legislative push to expand the current 11-item convenience store formulary to a maximum of 20 products, while concurrently lowering operational barriers, such as the mandatory 24-hour business requirement for participating convenience stores.With relevant revisions currently stalled in the National Assembly’s Health and Welfare Committee, the Minister's explicit public backing is expected to push strong legislative momentum to clear the subcommittee review phase during the latter half of the year.Regarding non-face-to-face treatments scheduled for implementation on December 26, the policy blueprint specifically mandated the 'stabilization and expansion of prescription drug delivery system'.This indicates that the administration intends to leverage the promulgation of enforcement decrees to radically broaden the eligibility criteria for home medication delivery, which is currently restricted to highly isolated island residents and designated rare disease cohorts.Industry insiders view the sudden escalation of multiple systemic flashpoints, guaranteed to provoke fierce blowback from the medical and pharmaceutical professions, as a decisive move to remove the ministerial 'underperformance' label that has previously shadowed the Minister's tenure. A political insider commented, "Minister Jeong is shifting from a cautious defensive posture to articulating unambiguous stances on structural reforms," and added, "Amid raised speculation regarding a potential cabinet reshuffle, this serves as a calculated tactical play to project external policy achievements by aggressively prioritizing presidential priorities."Furthermore, "This coincides with the presidential office's intensive audit of ministerial operational metrics and separate tracking of campaign pledge execution timelines," and added, "It functions as a direct response to the ruling party's demands for tangible milestones, while allowing Minister Jeong to project decisive legislative breakthrough capacity over stagnant healthcare files."
- Policy
- [Desk's View] Requirements for Priority Marketing Authorization system entry
- by Lee, Tak-Sun Jun 16, 2026 08:33am
- It has been a decade since the introduction of the Priority Marketing Authorization system. Launched in March 2015 alongside the implementation of the Approval-Patent Linkage System under the South Korea-US FTA negotiations, the Priority Marketing Authorization has become a core system of generic marketing authorization.The system's foundational framework has remained unchanged for the past 10 years. Securing three specific requirements grants a 9-month window of market exclusivity. To obtain first generic exclusivity, a developer must satisfy three criteria. First, filing the initial patent challenge against the original patent; second, receiving a favorable trial decision upholding the challenge; and third, submitting the earliest application for marketing authorization. Over the past decade, the generic regulatory system has undergone notable changes, including the implementation of the "1+3 limit" on shared and sub-consigned bioequivalence (BE) studies, alongside drug pricing adjustments that preserve higher price tiers only for generics backed by independently conducted BE trials. These institutional shifts are driving a structural rationalization within the generic drug sector. However, critics point out that the requirements for Priority Marketing Authorization do not align with shifting market realities. In particular, the provision governing the initial patent challenge is cited as a major factor eroding the practical value of generic market exclusivity. This is because the qualification is not limited to the first company to file a patent challenge, but extends to any competitor that files its own challenge within 14 days of that initial filing date. Drop-in filings often occur after an initial patent challenge is logged, as generic developers rush to secure co-exclusivity rights within the 14-day window to avoid falling behind on commercial launch timelines. While challengers must still secure a favorable trial decision and meet the earliest marketing authorization application requirement, it has become commonplace for firms to rush to satisfy the initial filing condition before mapping out an actual downstream strategy. These patent challenges place an immense administrative strain on the Intellectual Property Trial and Appeal Board (IPTAB) and resulting in a substantial waste of public and corporate resources due to ballooning litigation costs.Ultimately, the broad granting of exclusivity status to a large pack of concurrent applicants dilutes the commercial value of market exclusivity, undermining the core regulatory intent and utility of the system.As a result, voices within the sector are calling for the outright elimination of the 14-day grace period clause from the initial patent challenge requirement.Restricting eligibility for exclusivity to the single firm that executes the initial patent challenge would discourage the influx of indiscriminate generic filings and significantly strengthen the commercial value of generic exclusivity.Yet, given the unique dynamics of the South Korean pharmaceutical landscape, where more than 100 drugmakers compete in the generic space, abolishing the 14-day rule could be perceived by some as granting an unfair advantage to a single company or as systematically depriving competitors of market opportunities. Furthermore, since identical generics can enter the market immediately after the exclusivity window closes, and non-identical alternatives, such as salt variations, can bypass the marketing exclusivity altogether, limiting these exclusivity rights to a single developer dose not eliminate competitive dynamics from the marketplace.Granting a market-exclusivity window to a single firm would amplify the practical impact of the system and prevent competition driven by a surplus of identical products. Furthermore, this mechanism could act as a catalyst for structural rationalization, encouraging high-value pipeline over speculative generic development.Changes across foundational marketing authorization and drug pricing frameworks are evident. It is now the time to recalibrate policies governing patent challenges, which represent the true starting point of generic development. The Ministry of Food and Drug Safety (MFDS) must not dismiss the recommendations from the Approval-Patent Linkage System impact assessment report published late last year, which strongly emphasized the urgent need to elevate the practical effectiveness of the Priority Marketing Authorization.
- Policy
- Generic drug mkt dominated by "CDMO·multi-product entries"
- by Jung, Heung-Jun Jun 15, 2026 09:19am
- Academic conference hosted by the Korean Academy of Social and Administrative Pharmacy.A research project commissioned by the Ministry of Health and Welfare (MOHW) before the recent drug pricing system reform identified 'long-listed, multi-product pharmaceuticals' as a primary cause of overall inflation in pharmaceutical expenditures in South Korea.Increased contract manufacturing has led to an abundance of low-revenue, marginalized products. The average annual reimbursement per individual items posted less than KRW 1 billion, even for active pharmaceutical ingredients (APIs) with substantial claim amount.On June 12, key findings from the MOHW-commissioned research were presented at the Korean Academy of Social and Administrative Pharmacy's academic conference.According to the study, national expenditures on generics surged by 60% between 2017 and 2024, increasing from KRW 7.7661 trillion to KRW 12.4409 trillion, a net increase of KRW 4.7 trillion. This represents a 46.2% share of total pharmaceutical spending. Eun Mi Bae, a professor at the Korea University College of Pharmacy, explained that an analysis of the top 20 active ingredients by generic expenditure revealed an average of 83.4 individual products per ingredient. Professor Bae noted that medications that have been listed for an extended period predominated, with an average listing duration of 16.7 years.Within the top 10 therapeutic categories by National Health Insurance spending, dyslipidemia treatments consistently ranked number one from 2017 through 2024. Furthermore, the category expenditure expanded 2.2-fold relative to 2017 levels, reaching KRW 2.78 trillion in 2024.The researcher also emphasized the critical need for closer regulatory oversight as fixed-dose combination (FDC) therapies increasingly become mainstream.Professor Bae said, "Combination therapies are actively prescribed for chronic conditions. Within the statin market segment, sales of combination therapy products officially eclipsed those of monotherapy agents in 2023."The report further evaluated past regulatory interventions, specifically the differential generic pricing policy based on criteria requirements and the primary re-evaluation scheme, concluding that they yielded no statistically significant impact on reducing overall pharmaceutical expenditures. Professor Bae said, "The pharmaceutical expenditure share of the group satisfying both the in-house bioequivalence and DMF registration criteria skyrocketed from 15.4% to 32.4%. While the policies successfully induced market restructuring, neither the differential pricing model nor the re-evaluation measures delivered a meaningful downward impact on overall drug expenditures."Contract manufacturing explodes from 44% to 63% over 7 years…Proliferation of low-revenue products under KRW 1B The generic pharmaceutical market remains dominated by larger corporations with annual revenues exceeding KRW 80 billion. This segment commands nearly 80% of total insurance reimbursement claims, and its market share is expanding steadily. The generic claim amount percentage for pharmaceutical companies with revenues exceeding KRW 80 billion increased from 71.9% in 2017 to 83.6% in 2024. In contrast, the market share for firms generating less than KRW 80 billion contracted from 24.3% to 12.4% over the same period.Furthermore, the proportion of generic drugs in total insurance billing for designated "Innovative Pharmaceutical Companies" decreased from 49% to 37% during this period.Professor Eunah Han said, "Generics constitute up to 78% of the products sold by companies with revenues exceeding KRW 80 billion. However, individual items with annual billing under KRW 1 billion make up the largest proportion of their portfolios. Furthermore, since contract-manufactured items account for 57.7% of the portfolios of these larger corporations, even big corporates lack clear strategic differentiation." The report clearly documented a dramatic upward trend in sub-consigned production. The proportion of contract-manufactured items escalated sharply from 44% in 2017 to 63% in 2024. Although the absolute number of registered products increased, their share of total reimbursement billing grew marginally, moving from 30% to only 35%.This data indicates that low-revenue, marginalized products heavily drove market expansion. In therapeutic categories characterized by intense multi-product entry, an average of 54 distinct brands competed head-to-head for market share.The high reliance on contract manufacturing means operational disruptions at a single manufacturing facility can instantly trigger widespread supply vulnerabilities across the entire market.Eunah Han, a professor at the Yonsei University College of Pharmacy, pointed out, "Competitive multi-product market segments represent a small slice (about 15%) of the overall generic therapeutic landscape. Yet, they absorb 60% of total reimbursement claims and contain 60% of all registered products."The study concludes that slashing generic prices specifically in these competitive, multi-product segments would yield the greatest savings for the national insurance fund while minimizing broader shocks to drug supply and demand. "Generic pricing cuts are the starting point…considering follow-up measures, including CSO·Essential medicines"During the panel discussion at the venue, officials from the MOHW, the National Health Insurance Service (NHIS), and the Health Insurance Review and Assessment Service (HIRA), who spearheaded the pricing reform, met consensus on these structural vulnerabilities.Jong-hwan Lee, Department head of the Pharmaceutical Reimbursement Evaluation Committee at HIRA, stated, "While foreign regulatory systems continually depress generic prices over time, South Korea links reductions to the Price-Volume Agreement (PVA) mechanism, which results in price drops only when specific sales volumes are cleared. This creates a regulatory blind spot for smaller, low-volume generic medications."Lee mentioned that "Because the current system links pricing to maximum price rates, if a single product evades post-marketing price controls and sustains its peak price tier, late-entering generics automatically receive high pricing benchmark." Lee emphasized the pressing need to refine post-marketing price controls and initial price calculation metrics.The NHIS announced it would systematically manage expenditure structures and volume utilization patterns to build a concrete, data-driven foundation for structural improvements.Hyung-min Kim, Department head of the Department of Drug Management at NHIS, stated, "A significant portion of listed medications are neither actively manufactured nor supplied, which stalls healthy market competition and artificially keeps drug prices high." Kim stated that the NHIS will tighten its monitoring of unmanufactured and unbilled line items.Ki-Hyun Bae, an administrative officer in the Division of Health Insurance Benefits at the MOHWKim added, "While drug pricing drive expenditure growth, volume expansion exert a far greater influence, prompting the agency to continuously track the volume footprints of newly listed generics."The MOHW stressed that lowering the generic pricing baseline via the recent drug pricing reform is merely the initial phase of system reform. The MOHW revealed it is currently deciding follow-up interventions targeting CSO fees and optimized incentive system for essential medicines. Ki-Hyun Bae, an administrative officer in the Division of Health Insurance Benefits at the MOHW, stated, "Adjusting the generic ceiling price down to 45% through the drug pricing reform represents the absolute baseline before executing broader structural improvements. It establishes the groundwork to eliminate redundant expenditures and move forward."Bae added, "Media reports suggest average CSO commission fees amount to around 37%. Given the findings that individual generic items average under KRW 1 billion in annual billing, it is questionable whether this structure will last," and concluded, "The current situation where no voluntary suppliers step forward for essential medicines while a flood of products clusters exclusively in stable, low-risk market segments remains a critical challenge that the government must continuously resolve."
- Policy
- Seqirus’s flu vaccine fails to gain NIP status
- by Lee, Tak-Sun Jun 14, 2026 12:13pm
- CSL Seqirus Korea’s ambitious first bid to enter the National Immunization Program (NIP) has ended in failure. The company narrowly missed making the list in a fiercely competitive Public Procurement Service tender.According to industry and the Public Procurement Service (PPS) sources on June 10, the bid opening results for the ‘2026–2027 seasonal influenza vaccine procurement tender,’ for which the Korea Disease Control and Prevention Agency (KDCA) participated as the demand agency, showed that six companies were selected as final winners: SK Bioscience, GC Biopharma, Korea Vaccine, Sanofi-Aventis Korea, Boryung Biopharma, and Ilyang Pharmaceutical.The tender was conducted under a competitive desired-quantity bidding system, in which vaccine quantities are allocated to companies offering the lowest prices below the government's estimated price of KRW 9,690.07 per dose.The main topic of interest in this year's tender was whether CSL Seqirus Korea could successfully enter the NIP market. Seqirus bid at KRW 9,218 per dose and offered 1.2 million doses. Although the bid price was below the government's estimate, it was not low enough to surpass aggressive pricing from major domestic and international vaccine manufacturers.SK Bioscience submitted the lowest bid at KRW 8,851 per dose for 2.7 million doses, securing first place. GC Biopharma followed at KRW 8,920 for 2.66 million doses, Korea Vaccine at KRW 8,952 for 1.9 million doses, Sanofi-Aventis Korea at KRW 8,965 for 2.25 million doses, Boryung Biopharma at KRW 9,005 for 1.77 million doses, and then Ilyang Pharmaceutical at KRW 9,199 for 1.5 million doses.In contrast, Seqirus Korea's bid of KRW 9,218, which was just KRW 19 higher than Ilyang's, placed the company seventh. Although KDCA originally sought to procure 12.33 million doses, the cumulative winning bids had already secured 12.78 million doses by the time the sixth-ranked bidder was selected. As a result, Seqirus was automatically excluded from the final list.Final Successful Bidders for the 2026-2027 Influenza Vaccine Procurement Tender (Captured from the KONEPS/Nara Market Website)On KDCA’s part, the outcome represented a significant cost-saving achievement. The agency secured an additional 450,000 doses while paying prices substantially below its originally estimated unit cost of KRW 9,949. For participating companies, however, the tender effectively became a near-loss-making price war.CSL Seqirus Korea is the Korean subsidiary of CSL Seqirus, one of the world's leading influenza vaccine companies. In March, the company received Korean regulatory approval for Flucelvax Prefilled Syringe (a cell-cultured influenza surface antigen vaccine), raising expectations for a new generation of influenza vaccines in the domestic market.The vaccine is a WHO-recommended egg-free trivalent influenza vaccine produced using cell culture technology rather than eggs, reducing the risk of virus mutations that can occur during manufacturing. It is indicated for the prevention of influenza A and B infections in individuals aged six months and older.Seqirus Korea had hoped to secure stable NIP volumes through government procurement and rapidly expand its market share. However, following this setback, the company will now need to compete exclusively in the ‘private-pay 9non-reimbursed) vaccination market.’With established players such as GC Biopharma and SK Bioscience already leveraging their government-procurement volumes to strengthen market positions, industry observers are watching closely to see whether Seqirus Korea can carve out a niche in the non-reimbursed private market through collaboration with local partners, including Samjin Pharmaceutical, and through differentiated distribution strategies.
- Policy
- Roche's new obesity drug candidate wins nod for Phase III in KOR
- by Lee, Tak-Sun Jun 14, 2026 12:13pm
- Global pharmaceutical giant Roche’s next-generation obesity drug candidate is finally entering the final hurdle of Phase III clinical trials in South Korea. As the drug is regarded as a competitive agent to Novo Nordisk and Eli Lilly, which currently dominate the market, the pharma-biotech industry is focusing heavily on initiating this large-scale trial targeting domestic patients.On June 9, the Ministry of Food and Drug Safety (MFDS) officially approved an 'Investigational New Drug (IND) application filed by Roche Korea for a Phase III clinical trial evaluating the efficacy and safety of once-weekly RO7795068 (CT-388) in participants with obesity or overweight without type 2 diabetes.' Conducted as part of a global multicenter study, this trial aims to enroll 2,000 participants worldwide, with 144 participants allocated for South Korean patients with obesity. The clinical study commenced its local trial setup in February 2026 and is scheduled to run for approximately 2 years and 10 months until December 2028.The newly cleared 'RO7795068' is a once-weekly subcutaneous dual GLP-1/GIP receptor agonist (development code name: CT-388), which Roche secured through its approximately $2.7 billion acquisition of US biotech firm Carmot Therapeutics in December 2023. It shares the same mechanism of action as Eli Lilly's mega-blockbuster obesity drug Zepbound (tirzepatide, Korean product name as Mounjaro). Roche's CT-388 previously shocked the market with its recently disclosed Phase II data. When a high dose (24 mg) was administered to obese patients over 48 weeks, it demonstrated a phenomenal mean weight reduction of 22.5% compared to the placebo group. These Phase II trial results had two disgtinguishing features. First, the 'weight loss plateau,' a common limitation observed with existing GLP-1 class therapeutics, was not observed even at 48-week, as the weight reduction curve maintained a continuous downward trajectory. Second, a staggering 47.8% of patients in the highest-dose cohort achieved a 20% or greater weight reduction, while roughly one in four (26.1%) demonstrated explosive efficacy, losing over 30% of their body weight. The drug also showed excellent results in resolving comorbidities, achieving a milestone. 73% of participants with prediabetes reverted to normal blood glucose levels. Currently, the global obesity market is dominated by Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, which has led to challenges in manufacturing and supply keeping up with demand. However, industry experts anticipate that the market landscape could shift rapidly following Roche's entry into Phase III testing. When compared with the clinical datasets of frontrunners Wegovy (approx. 15% weight loss) and Zepbound (approx. 20%), the '48-week 22.5% reduction without a plateau' demonstrated by Roche's CT-388 represents figures capable of establishing a clear competitive edge. Notably, Roche structurally engineered the molecule to minimize receptor desensitization, which occurs where drug receptor responses rapidly diminish, thereby maximizing the duration of efficacy. The company's strategic goal is to surpass existing standard-of-care medications in both ease of administration and tolerability. A biotech industry insider stated, "If the first round of competition of the obesity drug was centered on 'which product takes the market first,' the second round that has just commenced is a battle over 'which product can reduce body weight more completely without plateaus and side effects,'" and added, "Followingh Roche officially launching its global Phase III program, including South Korea, Roche's trial agent has emerged as the most promising next-generation contender with potential of breaking the current duopoly held by Lilly and Novo Nordisk."Based on this MFDS approval, Roche Korea plans to collaborate closely with clinical trial sites, including major hospitals in South Korea, to accelerate patient recruitment and dosing. If the trial concludes successfully by the end of 2028 as scheduled, a three-way battle among Lilly, Novo, and Roche in the obesity market is projected to materialize as early as 2029.
- Policy
- Application for salt-modified version of palbociclib filed in Korea
- by Lee, Tak-Sun Jun 11, 2026 09:25am
- Pfizer's breast cancer treatment ‘Ibrance Tab’A salt-modified version of palbociclib (brand name: Ibrance), a breast cancer treatment, has been submitted for regulatory approval.Generic versions of palbociclib are expected to enter the market in March 2027, when the original Ibrance substance patent expires. Daewoong Pharmaceutical and Kwangdong Pharmaceutical have already secured first generic exclusivity for products containing the same active ingredient and are preparing for launch.Against this backdrop, a salt-modified palbociclib product has emerged as a new variable in the upcoming generic competition. The product is believed to have been developed by Boryung.According to the Ministry of Food and Drug Safety (MFDS) on June 10, a tablet formulation containing palbociclib hemiadipate was submitted for approval on May 7.The product is intended for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.Its approved indications are identical to those of the original Ibrance, including use in combination with an aromatase inhibitor as initial endocrine therapy in women and in combination with fulvestrant in women whose disease has progressed following endocrine therapy.Ibrance is Pfizer's oral targeted therapy for breast cancer. The drug generated KRW 23 billion in outpatient prescriptions last year, according to UBIST data.Domestic companies have long prepared for market entry upon expiration of Ibrance's substance patent by challenging patents and developing products. In addition to the substance patent, Ibrance’s formulation patents were invalidated through patent invalidation trials, while crystal-form patents were circumvented through product differentiation strategies.In particular, Daewoong Pharmaceutical and Kwangdong Pharmaceutical satisfied the requirements for first generic approval and secured first generic exclusivity rights.Daewoong's tablet product ‘Ranclib Tab’ and Kwangdong's capsule product ‘Alenci Cap’ obtained exclusive marketing rights from March 23, 2027, through December 22, 2027, the period immediately following expiration of the substance patent. During that period, other generic tablet and capsule formulations containing palbociclib cannot enter the market.Boryung, which had also successfully challenged the patents, failed to obtain first generic approval. Industry observers believe the company adopted a strategy to launch the product early in the market by bypassing the patent through a salt-modified product strategy.In December last year, Boryung challenged the crystal-form patent with a product based on ‘palbociclib hemiadipate crystalline particles,’ the same active ingredient used in the product for the current approval application. In April, the Intellectual Property Trial and Appeal Board ruled that the product did not fall within the scope of the patent claims.Accordingly, if Boryung's product satisfies certain conditions, such as the initial filing of marketing authorization, it is expected that they will be able to overcome the market exclusivity barrier created by Daewoong and Kwangdong, and launch the product simultaneously when the substance patent expires next year.Under Korea's Pharmaceutical Affairs Act, the sales injunction resulting from first generic exclusivity applies only to generics containing the same active ingredient. Since the 'hemiadipate' form applied for by Boryung differs chemically from the original 'base-free' (salt-free) form, it falls outside the scope of Daewoong and Kwangdong's exclusive rights for tablets and capsules. As a result, Boryung will be able to launch its product immediately following the expiration of the substance patent in March 2027."Boryung has continued expanding investment in its oncology business while strengthening its breast cancer treatment portfolio.The company already markets breast cancer therapies including ‘Xeloda’ and ‘Taxol,’ as well as ‘Samfenet,’ a biosimilar version of Herjuma developed by Samsung Bioepis. In 2024, the company also secured ‘Nerlynx Tab.’ through a co-promotion agreement with Bixink Therapeutics.The company further completed preparations for palbociclib commercialization by obtaining reimbursement listing last year for Letrobo Tab, a letrozole product used in combination with palbociclib.Meanwhile, both capsule and tablet formulations of Ibrance are currently reimbursed in Korea. Pfizer has introduced a tablet version that improves upon the food effect (which previously required administration immediately after a meal) of the existing capsule formulation.
- Policy
- Drug price cuts for listed drugs to be discussed in detail next week
- by Jung, Heung-Jun Jun 11, 2026 09:24am
- The Ministry of Health and Welfare (MOHW) plans to convene a working-level consultative meeting with the pharmaceutical industry next week and discuss detailed issues related to drug pricing reform, including criteria for reducing the prices of already-listed medicines.At the previous working-group meeting held in late April, participants discussed calculation rates, management of multiple product listings, and the implementation cycle for drug price reductions. However, price cuts for existing listed drugs were not discussed at the meeting, making the issue a key agenda for the upcoming meeting.According to industry sources and relevant authorities on June 9, the MOHW will hold another working-group meeting with pharmaceutical companies next week as part of efforts to implement its drug pricing reform plan.The April meeting was attended by officials from the Health Insurance Review and Assessment Service (HIRA), the National Health Insurance Service (NHIS), and pharmaceutical companies. Participants discussed various measures for reforming the pharmaceutical pricing system. Following the meeting, the ministry accepted the feedback and issued a legislative notice for amendments to the "Criteria for the Determination and Adjustment of Pharmaceuticals."At that time, discussions on listed drug price reductions were not included on the agenda. The meeting concluded with a consensus that further discussion would be necessary.As a result, detailed criteria distinguishing Phase 1 and Phase 2 products subject to price cuts of listed drugs will likely be discussed at the next meeting.The overall framework has already been established - price cuts for existing listed drugs will begin at the end of this year and be implemented gradually over a ten-year period through 2036. However, products will be divided into Phase 1 and Phase 2 categories based on a 2012 cutoff, with different timelines for when the price reductions take effect.To date, not all products have been classified into either Phase 1 or Phase 2. Additional discussions are needed regarding products for which the applicable criteria remain unclear, such as fixed-dose combination drugs and other products. The industry and regulators are still discussing how these products should be categorized under the proposed framework.For instance, there may be disagreements regarding whether a combination product should be classified as a Phase 1 product when some components of a combination drug still retain patent protection or PMS (Post-Marketing Surveillance) status.Unlike the industry's stance, the government maintains that if even a single component was listed before 2012, it should be classified as a Phase 1 drug.The distinction between Phase 1 and Phase 2 products could have a significant impact on the pharmaceutical industry. Products classified as Phase 2 would begin price reductions in 2030 and gradually converge to a reimbursement rate of 45% by 2036.Given the revenue implications of delaying the reduction schedule by 4 years, pharmaceutical companies are expected to seek classification of as many products as possible under the more favorable Phase 2 category.
- Policy
- Will PPC injections make a comeback? MFDS review underway
- by Lee, Tak-Sun Jun 10, 2026 08:41am
- AI-generated imagePPC (phosphatidylcholine) injections, which dominated the aesthetic and obesity market in the late 2000s but subsequently disappeared, are preparing for a spectacular comeback with a formal marketing authorization in hand. In the past, PPC injections were approved as an adjunct treatment for hepatic coma caused by liver cirrhosis, but they became controversial due to their widespread "off-label" use for fat reduction.According to industry sources on the 9th, the Ministry of Food and Drug Safety (MFDS) recently initiated a Good Clinical Practice (GCP) inspection regarding the application for a change in product approval for "Amiraju Inj. 5mL," a PPC-based drug. The GCP inspection is a critical final hurdle where the MFDS verifies the reliability of clinical data just before granting drug approval. This implies that the MFDS has entered the final stages of the product approval review.Amipharm has been known to have applied for approval. The company has developed a proprietary formulation technology that completely eliminates surfactants and utilizes only pure soybean-derived phosphatidylcholine (PPC) to induce the "apoptosis" (programmed cell death) in fat cells. Unlike earlier formulations that forcibly caused cell necrosis, the new composition selectively induces the death of fat cells only, thereby significantly reducing pain and swelling while maintaining a semi-permanent fat reduction effect.Amipharm successfully completed a domestic Phase III clinical trial involving 252 patients with submental (double chin) fat, demonstrating a high improvement rate of approximately 73.7%. Following this, the company applied for formal product approval as a ‘localized fat reduction agent’ and is known to be s proceeding simultaneously with manufacturing license approval procedures.PPC injections like Lipobin Inj were originally approved as prescription drugs for the treatment of hepatic coma associated with liver cirrhosis. However, rumors that American pop star Britney Spears had lost weight using PPC injections fueled a craze in aesthetic clinics and plastic surgery practices, where the products were widely prescribed off-label to reduce fat under the chin and in the upper arms.The product's popularity, however, did not last. Manufacturers ultimately failed to demonstrate post-marketing efficacy for the originally approved indication of hepatic coma, while growing criticism over the indiscriminate use of PPC injections as obesity treatments further intensified. As a result, the products were eventually withdrawn from the Korean market.An industry official commented, “It is highly meaningful that PPC, a substance that once disappeared from the aesthetic market, is returning as a formally approved therapeutic product after demonstrating its safety. If the MFDS inspection proceeds smoothly, official marketing authorization is certainly within reach.”
- Policy
- OTC Formulation changes to become easier in KOR
- by Lee, Tak-Sun Jun 09, 2026 10:01am
- Going forward, companies seeking approval for over-the-counter (OTC) drugs that use the same route of administration as an already approved or notified product but differ only in formulation will be required to submit significantly fewer review documents. By establishing specific criteria for what constitutes a ‘minor formulation difference,’ a concept that had previously remained ambiguous, the revision is expected to substantially reduce the burden associated with product development and approval changes for pharmaceutical companies.The Ministry of Food and Drug Safety (MFDS) announced on the 5th that it had issued a public notice of a proposed amendment to the ‘Regulations on the Approval, Notification, and Review of Pharmaceutical Products.’ The revision was introduced to address shortcomings in the current pharmaceutical approval, notification, and review system while rationalizing existing regulations.The core objective of the amendment is to streamline the administrative procedure by clearly specifying which supporting documents are required when changing the formulation of OTC drugs.Previously, if a company sought approval for a new product that had the same route of administration as an already approved or notified drug but differed in formulation, it was required to submit extensive review materials, such as head-to-head trial data or bioequivalence study data.However, under the revised proposal (Appendix 1), if the difference between the proposed OTC formulation and the existing formulation is considered ‘minor’ and falls within the same specified category, existing data for the drug may be used in place of the required review data.According to examples provided by the MFDS, eligible formulation changes include: Changes among tablets (plain tablets, sugar-coated tablets, and non-enteric film-coated tablets); capsule formulations; granules and powders; Changes among ointments, creams, gels, topical solutions, and topical powders; Changes among oral liquid formulations (excluding emulsions and suspensions) and syrups; Changes between cataplasms and adhesive patches.The pharmaceutical industry expects the measure to significantly reduce both development time and costs when diversifying OTC formulations to better align with consumer preferences and improve dosing convenience.In addition to simplifying formulation-change procedures, the amendment includes a number of broader regulatory rationalization measures.For medical high-pressure gases such as oxygen, a new exemption provision has been established, allowing safety validation data (long-term stability and accelerated stability study results) to be replaced by prior use cases for already approved or registered products. For orphan drug products whose active pharmaceutical ingredient quality data have already been submitted, multiple specifications for the active ingredient may be listed if it can be demonstrated that they do not affect the quality of the finished pharmaceutical product.In addition, a new provision stipulates that when only the name of a general test method in an official compendium has changed without any modification to the test procedure itself, the approval or notification will be deemed automatically updated without requiring a separate amendment procedure. In addition, efforts to refine legal terminology into easy-to-understand Korean, such as replacing Japanese-style Chinese characters like ' sujaedoen (recorded)’ with 'sillin(included)’ and ' jeokbu (judgment of suitability)’ with 'judgment of conformity/non-conformity’ were also includedThe MFDS will accept public comments on the proposed amendment until August 4, 2026. The revised regulation will take effect immediately upon promulgation and will apply to pharmaceutical products for which manufacturing, marketing, or import approval and notification applications (including amendments) are first submitted after the effective date.
- Policy
- GLP-1 obesity drugs may receive 'concern for misuse and abuse' designation
- by Lee, Tak-Sun Jun 09, 2026 10:01am
- AI-generated imageAs the Ministry of Food and Drug Safety (MFDS) pursues the designation of GLP-1 obesity treatments as 'drugs of concern for misuse and abuse,' it has released an analysis showing that the public interest benefits of protecting citizens' rights to know and to health are significant.Consequently, GLP-1 obesity treatments containing liraglutide, semaglutide, and tirzepatide are highly likely to be designated as drugs subject to concern for misuse and abuse following a collection of industry opinions. Once designated as a drug subject to concern for misuse and abuse, warning phrases will become mandatory on packaging, and sales without a prescription will be prohibited even in areas exempt from the separation of prescribing and dispensing.The MFDS issued an administrative notice on the 5th regarding a partial amendment to the "Regulations on the Designation of Drugs Subject to Concern for Misuse and Abuse," which features these primary measures. The MFDS has also concluded its economic and social feasibility review through a regulatory impact assessment report.6.3-fold increase in supply...severe safety insensitivity including inappropriate prescribing for pediatrics and pregnant womenThe background of the MFDS is to tighten regulatory oversight, which lies in the recent explosive growth of the obesity treatment market and the resulting indiscriminate misuse and abuse.According to the regulatory impact assessment report, the volume of GLP-1 receptor agonist obesity treatments (liraglutide, semaglutide, and tirzepatide) imported and supplied domestically increased by 6.3-fold (approximately KRW 901.0 billion) in just one year, skyrocketing from around KRW 169.9 billion in 2024 to approximately KRW 1.0709 trillion in 2025.The problem is that instances where these medicines are abused for simple cosmetic weight loss by individuals with normal body weights or are illegally distributed are surfacing consecutively. In fact, it was verified that 69 cases of inappropriate prescribing occurred for pediatric patients under the age of 12 and 194 cases for pregnant women. At the same time, crackdowns by relevant authorities revealed a sharp increase in the detection of online false or exaggerated advertisements and illegal distribution.Notably, pharmacy supply volumes in 'areas exempt from the separation of prescribing and dispensing', such as remote islands and mountainous regions lacking physicians, have also experienced a steep spike. For the flagship product 'Wegovy', supply volume to pharmacies in these exempt regions increased by 975.7% year-over-year.History of Designations for 'Drugs Subject to Concern for Misuse and Abuse'There are two core measures newly established through the introduction of this regulation. First, it restricts the sale of these obesity treatments so that they can be dispensed only upon a physician's prescription at pharmacies nationwide, including those located in areas exempt from the separation of prescribing and dispensing. The intent is to block indiscriminate acquisition channels that bypass prescriptions fundamentally.Second, pharmaceutical manufacturers and importers must clearly print the phrase "Drug Subject to Concern for Misuse and Abuse" on product containers, packaging, and package inserts. Through this, the agency plans to heighten awareness regarding drug misuse and abuse among both medical professionals and consumers.Direct costs to the pharmaceutical industry estimated at KRW 24 Million... "Public interest benefits overwhelmingly outweigh compliance costs"The MFDS found that the economic burden imposed on the pharmaceutical industry by this regulation remains marginal. Currently, there are a total of 24 authorized obesity treatment products containing the relevant active ingredients in South Korea. Upon calculating the costs of modifying labeling materials, such as replacing printing ink and copper plates, for the 12 items currently launched and actively selling in the market, it was estimated that a one-time direct cost of approximately KRW 2 million per product, totaling KRW 24 million (equivalent to an annualized net cost of KRW 2.9 million), would be incurred. Six products that have not yet been launched were excluded from the cost-incurring factors.The MFDS emphasized, "Compared to private losses such as material modification expenses for certain regulated entities or revenue declines for pharmacies, the public interest benefits of preventing side effects from inappropriate drug administration and protecting the citizens' right to know and right to health are significant."The MFDS plans to gather both positive and negative opinions on this administrative notice through June 26, 2026, and to implement the policy immediately. Consumers and the industry will be granted a one-year transitional grace period to use pre-manufactured packaging materials produced before the implementation date.
