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- 2026-04-24 08:27:11
- Policy
- First matching-form Ofev generic listed at half price
- by Jung, Heung-Jun Feb 24, 2026 03:55pm
- A generic version of the chronic fibrotic interstitial lung disease treatment Ofev Soft Cap (nintedanib esylate) with the same formulation will be listed for reimbursement for the first time.With its reimbursement entry at a price more than 50% lower than the original, full-scale market competition is expected.According to industry sources on the 20th, Ildong Pharmaceutical’s Cuninta Soft Cap 100 mg and 150 mg will be added to the March reimbursement list.The substance patent for Boehringer Ingelheim Korea's Ofev Soft Capsules expired in January last year. Subsequently, generic companies have successively launched their versions.However, unlike the original drug, those products obtained approval in tablet formulations. From July last year, Yungjin Pharm, Ildong Pharmaceutical, Daewoong Pharmaceutical, Kolon Pharmaceutical, and others entered reimbursement. Whan In Pahrm also received approval for Ofenib Tab, but the drug is yet to be listed for reimbursement.Until now, no reimbursed generic matching Ofev’s soft capsule formulation has been available. Ildong Pharmaceutical is expected to be the first to list a soft capsule generic, Cuninta Soft Cap, following its release of Cuninta Tab.Cuninta Tab 150 mg was previously listed at KRW 13,500, roughly half the price of Ofev Soft Cap, which was priced at KRW 26,220.Although generics designated as orphan drugs could receive equivalent pricing to the original, manufacturers pursued lower prices to strengthen market competitiveness.The reimbursement ceiling prices for Cuninta Soft Cap 100 mg and 150 mg are set at KRW 8,500 and KRW 13,500, respectively. Notably, the lower dose represents about 40% of the originator’s 100 mg price of KRW 20,960.Where earlier competition strategies relied on tablet differentiation and lower pricing, manufacturers can now seek prescription expansion based on identical formulation at half the cost.Because switching prescriptions within the same formulation is expected to face less patient resistance, Ildong Pharmaceutical is anticipated to intensify its competitive positioning against Ofev.Given that Ofev entered reimbursement relatively late, 8 years after domestic approval, Ofev is expected to face intensifying competition from the later entrant generics.
- Policy
- Government to establish bioequivalence standards for complex generics
- by Lee, Jeong-Hwan Feb 24, 2026 03:55pm
- The government is moving forward with the development of guidelines, including bioequivalence evaluation standards for complex generic drugs.This initiative aims to support the rapid development of complex generics as market entry for new technology and new concept drugs increases.Formulations targeted for new assessment criteria and testing methodologies include oral agents, injectables, inhalation products, and ophthalmic preparations.On the 20th, the National Institute of Food and Drug Safety Evaluation (NIFDS) under the Ministry of Food and Drug Safety (MFDS) announced the launch of a research project titled the “New Technology and New Concept Drug Guideline Development Project”.To develop bioequivalence assessment standards and testing method guidelines for complex generics, the Ministry of Health and Welfare (MOHW) will establish a multi-layered advisory framework involving industry, academia, and regulatory experts. Policy decisions will be made through an expert committee following internal review for stage-by-stage examination and verification.The research will define the concept of complex generics and conduct comparative analyses of domestic pharmaceutical industry demand alongside guideline frameworks from major global regulatory authorities to create new guidelines.Guidelines currently operated by the US FDA, European EMA, and Japan PMDA will be analyzed. Priorities for new guideline development will be determined based on technological impact, industry needs, and regulatory necessity.Subsequently, it will present general evaluation principles applicable to all dosage forms of complex generics and publish a reference manual to support development.In addition, bioequivalence guidelines specific to complex generics will be developed. It plans to create equivalence evaluation guidelines for oral, injectable, inhaled, and ophthalmic combination generics, validate them through a separate expert advisory body, including the Ministry of Food and Drug Safety (MFDS), and then finalize them.For this year, oral formulations selected for guideline development include pentosan polysulfate sodium products, ferric citrate hydrate capsules, and mesalamine extended-release tablets.Injectable products include dexamethasone extended-release implants and paliperidone palmitate long-acting injections. Inhalation products cover budesonide, formoterol fumarate inhalation aerosols, fluticasone propionate inhalers, and fluticasone propionate/salmeterol xinafoate inhalation powders.Ophthalmic formulations include brinzolamide suspension eye drops and prednisolone acetate suspension eye drops.Notably, authorities plan to establish a collaborative framework with the task force supporting rapid drug development guidelines. Once completed, newly developed guidelines will be promoted to industry and academic stakeholders, alongside implementation activities such as conferences.NIFDS stated, “We plan to develop more than 10 bioequivalence guidelines for complex generics and publish a project report. Through technological support for complex generics, we aim to accelerate the timely commercialization of high-quality generics while strengthening review reliability and transparency through science-based guidelines.”
- Policy
- Backlash mounts to drug price reduction reform plan
- by Lee, Jeong-Hwan Feb 24, 2026 03:55pm
- The Korean pharmaceutical industry continues criticizing that the background of the Minister of Health and Welfare (MOHW)'s drug pricing system reform, which includes 'calculation criteria for impact of drug price reductions' and 'preferential drug price criteria,' is unreasonable.The MOHW calculated simulation results for losses incurred from drug price reductions based on total sales amount. However, the view is that the calculation standard itself is flawed, as sales amount includes all accounting elements involved in the manufacturing and production of medicines.Furthermore, the criticism is that preferential drug price clauses based on whether a company is certified as an Innovative Pharmaceutical Company or on its ratio of new drug Research and Development (R&D) expenditure to sales are inappropriate because they are arrived at unilaterally, without proper agreement between the government and the industry.On the 22nd, the pharmaceutical industry voiced concerns about MOHW's unilateral push for drug pricing reform, stating, "The justification for the price reduction is unclear, and such administration significantly undermines trust in the government, leading to results that run counter to the fostering of the global pharmaceutical industry."On the 20th, the Health Insurance Policy Deliberation Committee (HIPDC) subcommittee excluded the drug pricing system reform plan, including the price reduction for currently listed generics, from its agenda.The MOHW cited insufficient gathering of industry opinions and said it would continue communicating with the industry until next month's (March) HIPDC meeting.Despite the MOHW’s decision to defer or postpone the agenda, the pharmaceutical industry remains skeptical about the possibility of revisions to the reform plan. This is due to the observation that the MOHW has not shown a proactive negotiation attempts thus far.Korean pharmaceutical companies cite the MOHW's methodology for calculating the impact of drug price reductions as the biggest issue.It is reported that the MOHW, based on simulation results analyzing the financial impact after price reductions using the sales revenue of several domestic pharmaceutical companies operating the generic business, concluded that revenue losses would be minimal even if the generic price calculation rate were lowered to 40%.Furthermore, the ministry believes that its reform plan is sufficiently valid and consistent, having derived results showing that certified innovative pharmaceutical companies or those with a high proportion of new drug R&D relative to sales would remain relatively unaffected by the price reductions.Korea's domestic pharmaceutical companies maintain that if the MOHW simulates the impact of price reductions based solely on total sales revenue or simple operating profit, an accurate evaluation is impossible.The reason is that a simulation based on sales revenue calculates figures by including every accounting element without exception. In contrast, one based on operating profit excludes selling, general, and administrative (SG&A) expenses. This evaluation method is impossible to reflect the innovation of pharmaceutical companies that have substantially contributed to the development of the domestic industry.In particular, while the MOHW has stated multiple times that the purpose of this drug pricing system reform is to foster the pharmaceutical industry rather than reduce health insurance drug expenditures, the pharmaceutical industry argues that reducing generic drug prices significantly while claiming to foster the industry is contradictory.The criticism is that the ministry's administrative goal, which it seeks to achieve through price reductions, is unclear.An official from domestic Pharmaceutical Company A pointed out, "The sales revenue evaluation, which is the standard for the MOHW’s impact simulation, is flawed as it includes all accounting elements," and added, "They must divert from single standards like sales revenue, perform a value evaluation considering various factors, and then proceed with simulations in a direction that grows the pharmaceutical industry and the drug market."Then added, "The MOHW changed the health insurance listing method for drugs from a negative list to a positive list system," and added, "This implies that the governemtn will make value judgments on drug prices. Therefore, all-at-once reduction of drugs listed through this system means the government considers existing medicines to have no value and intends to suppress the market."An official from domestic Pharmaceutical Company B also expressed, "The MOHW can analyze the reduction in pharmaceutical companies' revenue quite precisely through health insurance claim amounts or supply history reports. It is puzzling why they designed the drug price reduction and the pricing system reform plan with a simulation that excludes such big data when it is available for use."The official stated, "The pharmaceutical industry will be able to trust the government again only if the MOHW discloses transparent data regarding the evidence and standards used to design the drug pricing system reform and shows a willingness to negotiate," and added, "For now, meetings between the MOHW and the pharmaceutical industry may become a superficial formality, aimed at filing a quota of superficial mutual consultations."
- Policy
- Imjudo + Imfinzi comb to enter reimb list next month
- by Jung, Heung-Jun Feb 23, 2026 09:16am
- AstraZeneca Korea's liver cancer treatment, Imjudo (tremelimumab), will be included in the reimbursement list next month. This follows three months after the Drug Benefit Evaluation Committee (DBEC) approved combination therapy with Imfinzi.It is reported that a ceiling price of KRW 16.5 million has been set for this newly listed high-cost drug. Treatment access to hepatocellular carcinoma treatment is expected to improve significantly.According to industry sources on the 20th, AstraZeneca Korea's Imjudo Injection (0.3g/15mL) will be reimbursed starting in March.In November last year, the DBEC approved the reimbursement appropriateness of Imjudo as 'first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma in combination with durvalumab.'The listing process proceeded smoothly as drug price negotiations with the National Health Insurance Service (NHIS) began in December. Following the conclusion of price negotiations, insurance coverage is scheduled to begin in March.Imjudo was a drug for which requests for rapid listing were made during the Ministry of Health and Welfare (MOHW)'s National Assembly audit last year. At that time, the National Assembly inquired about plans to expand the reimbursement evaluation method, given the drug's distinct single-dose administration.According to the MOHW's response at the time, an application for health insurance coverage for Imjudo was filed in March last year, and the DBEC conducted a review of the drug cost comparison criteria in September of the same year.However, the DBEC delivered a reconsideration decision regarding the combination therapy with Imfinzi last September. After that, Imjudo's appropriateness for reimbursement was recognized during the DBEC reconsideration in November.Analysis suggests that the government's designation of a flexible application of the Incremental Cost-Effectiveness Ratio (ICER) value for Imjudo, second since the ADC anticancer drug 'Trodelvy (sacituzumab govitecan)', facilitated the smooth winding up of the drug price negotiations.
- Policy
- Recall of GSK's antiviral 'Valtrex Tab 500mg' over impurities
- by Lee, Tak-Sun Feb 23, 2026 09:16am
- Antiviral medication 'Valtrex Tab 500mg,' used to treat shinglesA recall has been initiated for certain batches of GlaxoSmithKline's antiviral medication, Valtrex Tab 500mg (valacyclovir hydrochloride), after nitrosamine impurities were detected above the permissible limit.This is the first recall of a valacyclovir-containing formulation due to impurities.The Ministry of Food and Drug Safety (MFDS) announced on the 20th that it has issued an operator-led recall order for specific manufacturing units of Valtrex Tab. 500mg that exceeded the Acceptable Daily Intake (ADI) of the nitrosamine impurity N-nitroso-N-ethyl-valacyclovir.The affected batch numbers are V53B (expiry 2027-04-24) and YR9K (expiry 2027-06-04).This product received domestic approval in 2005 and is indicated for ▲Shingles ▲Treatment of initial and recurrent genital herpes infections ▲Suppression of recurrent genital herpes infections ▲Reduction of transmission of genital herpes when used as suppressive therapy in combination with safer sex practices ▲Prophylaxis of cytomegalovirus (CMV) infection following kidney transplantation ▲Ccold sores ▲Treatment of chickenpox in immunocompetent pediatric patients aged 2 to under 18 years.As of 2024, the import performance of the drug totalUSD 4,137,731 (approximately KRW 6 billion). The ADI for N-nitroso-N-ethyl-valacyclovir in valacyclovir components is set at 400ng per day.The announced impurity is N-nitrosamine, a potential carcinogen and mutagen that can be generated at the ethylamine site of valacyclovir. It is known to form in trace amounts during the synthesis of the Active Pharmaceutical Ingredient (API) itself or through reactions during storage.Currently, 17 valacyclovir products are approved for sale in the Korean market. Attention is now focused on whether the recall of the original product will expand to include generic versions.
- Policy
- Regulations on INN prescribing·warehouse pharmacies
- by Lee, Jeong-Hwan Feb 20, 2026 10:04am
- It is highly likely that bills to mandate International Nonproprietary Names (INN) prescribing limited to supply-unstable drugs designated by the government, as well as bills to strengthen regulations on the signage, advertising, and opening scale standards of warehouse-type pharmacies, will be considered at the National Assembly Health and Welfare Committee's Legislation Subcommittee scheduled for the end of this month.This is because the decision by the lawmakers who proposed the relevant legislation to request the ruling and opposition party leadership of the Health and Welfare Committee to prioritize the review of the limited generic prescribing bill and the bill aimed at resolving drug misuse and abuse caused by the opening of warehouse-type pharmacies.On the 13th, the Health and Welfare Committee requested that ruling and opposition members submit the agenda for the First Legislation Subcommittee, which is expected to be held on the 26th.However, sources report that since the February subcommittee schedule falls immediately after the Lunar New Year holiday, and the leadership has agreed to the March plenary session, the New Year's business reports from relevant ministries, and the holding of the subcommittee, each lawmaker's office has been advised to submit only one agenda item.Despite this limitation, the bill to strengthen the supply chain for supply-unstable drugs and mandate limited generic prescribing, along with the bill to regulate the signage, advertising, and opening scale of warehouse-style pharmacies, are expected to be the top priority for the February subcommittee.Both bills are considered bills affecting daily lives, and resolving the drug supply instability issue is a national task of the new administration. Furthermore, the bill to strengthen regulations on warehouse-type pharmacies has gained urgency as large-scale warehouse-type pharmacies have recently opened in Seoul and other parts of the country, intensifying the debate between proponents and opponents and increasing the need to address potential side effects through legislative review.The bill details to resolve the drug supply instability crisis allows the Minister of Health and Welfare to designate supply-unstable drugs through the deliberation of the Drug Supply Management Committee. Among these, for drugs designated for emergency production or import, the bill permits pharmaceutical companies (manufacturers and importers) to place emergency production or import orders.Notably, the bill mandates that physicians write the generic name rather than the brand name on prescriptions for supply-unstable drugs, with penalties for violations. This provision aims to support the safe supply of medicines to patients by mandating limited generic prescribing.Representative Jang Jong-tae, who proposed the bill to resolve the drug supply instability issue, stated his legislative intent: "Recently, drug supply instability has been occurring frequently due to reasons such as temporary surges in demand, suspension of supply, and difficulties in securing raw materials," added, "Despite being a problem that threatens the public's right to health and causes confusion in the healthcare field, the current law lacks provisions regarding the response to drug supply instability."The bill to regulate warehouse-type pharmacies primarily prohibits the use of terms such as 'warehouse,' 'plant,' or 'factory' on pharmacy signs or promotional materials. It also mandates a preliminary review by the Pharmacy Opening Committee under the provincial governor or metropolitan mayor when an individual intends to register the opening of a pharmacy above a certain scale.The legislative goal is to prevent the incitement of excessive drug consumption and misuse among consumers and to strengthen the preliminary review authority of local governments and pharmacist associations regarding the opening of deformed pharmacies.Democratic Party Representatives Seo Young-seok, Nam In-soon, Kim Yun, Jeon Hyun-hee, and Jang Jong-tae have each proposed related legislation.An official from a ruling party member’s office on the Health and Welfare Committee explained, "We plan to submit the agenda items for the February subcommittee within the deadline," added, "The bill to resolve the drug supply instability crisis has high necessity and urgency for discussion, so we plan to request it as a first-priority bill for tabling."Another official from a ruling party member’s office stated, "As warehouse-type pharmacies have opened in several locations, it has become a national interest. The Ministry of Health and Welfare has also begun drafting regulations to prevent side effects, such as drug misuse, at warehouse-type pharmacies," and concluded, "It is necessary to accelerate the legislative review."
- Policy
- Weighted average price of apixaban falls 24%
- by Jung, Heung-Jun Feb 20, 2026 10:04am
- The weighted average price of apixaban declined by 24% last year, driven by increasing market penetration of generic products competing with the original anticoagulant Eliquis (apixaban) and reductions in reimbursement ceiling prices.Further declines are expected this year as generic competition intensifies, with products such as Chong Kun Dang’s Liquisia and Samjin Pharmaceutical’s Elxaban expanding their market presence.According to the Health Insurance Review & Assessment Service (HIRA)’s 2025 annual weighted average prices by active ingredient data, apixaban’s weighted average price fell from KRW 744 to KRW 566 year-over-year.BMS Pharmaceutical Korea’s Eliquis has been engaged in market share competition with generics since the year before last. Pharmaceutical companies that had withdrawn from the market after losing patent lawsuits relaunched their generics, and last year they launched aggressive market penetration efforts, including voluntary price reductions.Chong Kun Dang’s Liquisia reduced its reimbursement ceiling price from KRW 570 to KRW 567 through a voluntary price cut in October last year. Samjin Pharmaceutical’s Elxaban, expanding its presence in tertiary hospitals, is priced at KRW 550. Boryung’s BRapix also voluntarily reduced its ceiling price from KRW 724 to KRW 549 starting last November.Eliquis itself saw its ceiling price reduced from KRW 745 to KRW 570 last September following the reentry of its generic versions. All in all, the weighted average price of apixaban declined sharply within a single year due to generic relaunches and price adjustments.Despite this decline, apixaban’s weighted average price remains close to Eliquis’s ceiling price. This may indicate that generic penetration, while increasing, is not yet dominant enough to drive deeper price erosion.It also indicates that aggressive low-price bidding to enter tertiary hospitals has not yet occurred. Price management is being well-executed even amid market competition.The extent of further declines in the weighted average price for both the first and second halves of this year will likely be determined by the expansion of generics' market share. The key factor will be changes in market share held by Samjin and Boryung, which are expanding prescriptions using price competitiveness as their weapon.According to pharmaceutical market research firm UBIST, Eliquis sales declined from KRW 77.3 billion in 2023 to KRW 74.2 billion in 2024, representing a 3.9% decrease. The impact of generic re-entry is expected to continue to grow.Prior to market withdrawal following patent litigation losses, apixaban generics held a 24% market share. As of the third quarter of last year, their share stood at around 13% post-relaunch. Therefore, even considering only the previous market share, there remains potential for approximately 11% growth.
- Policy
- Takhzyro to be reimbursed from next month
- by Lee, Jeong-Hwan Feb 20, 2026 10:04am
- Takeda Korea’s hereditary angioedema treatment Takhzyro (lanadelumab) will be newly added to the National Health Insurance reimbursement list starting next month, approximately 5 years after receiving domestic marketing approval.Yuhan’s allergic rhinitis therapy Ryaltris Nasal Spray will also see an expansion of its reimbursement criteria.Currently reimbursed only for adolescents aged 12 and older and adults, Ryaltris’s coverage will be extended to pediatric patients aged 6 to 11.In addition, the reimbursement scope for the rare autoinflammatory disease treatment Kineret Inj (anakinra) will be explicitly revised to include treatment of macrophage activation syndrome (MAS).On the 19th, the Ministry of Health and Welfare (MOHW) issued a pre-announcement of a partial revision to the notification detailing reimbursement standards and application methods for pharmaceutical benefits.Under the revision, the Takhzyro Prefilled Syringe will be newly reimbursed effective March 1.Eligible patients include adolescents aged 12 and older and adults diagnosed with hereditary angioedema (Type 1 or Type 2), confirmed via serum testing for C1-esterase inhibitor deficiency or dysfunction (quantitative or functional), who meet the following conditions.Either they must have experienced attacks requiring emergency treatment (icatibant injection) at least 3 times per month on average over the previous 6 months, despite receiving oral danazol for at least 6 months, or they must have experienced a similar frequency of attacks if danazol could not be administered due to contraindications or adverse effects.After using Takhzyro for 6 months, if the average monthly number of episodes requiring emergency treatment (icatibant injection) has decreased by at least 50% compared to the initial treatment period, an additional 6 months of administration is approved.Subsequent reimbursement will require reassessment every six months, with continued coverage contingent upon maintaining the initial 6-month response level.However, after 6 months from the initial administration date, for patients showing stable disease activity and no adverse effects, self-administration is permitted following appropriate education on the administration method, based on the physician's judgment. Self-injection can be prescribed for up to a 2-month supply.Patients must complete a ‘patient medication diary’ to verify the medication administration period, with healthcare institutions responsible for its oversight.Takhzyro must be prescribed by a specialist with experience treating patients with hereditary angioedema. Objective documentation (medical records, test results, etc.) regarding the patient's eligibility for initial administration and response evaluation for continued administration must be submitted.In the case of the ENT medication Ryaltris Nasal Spray, its reimbursement, which was previously limited to patients aged 12 and older, will be expanded, effective March 1, to include children aged 6 to 11. However, the administration must strictly follow the indicated dosage and administration guidelines.Meanwhile, the reimbursement scope for Kineret Inj will be clarified in accordance with the approval conditions set by the Minister of Food and Drug Safety.Coverage will now include treatment for chronic infantile neurologic cutaneous and articular syndrome (CINCA), cytokine release syndrome (CRS) potentially occurring after CAR-T cell therapy, neurotoxicity syndrome, hemophagocytic lymphohistiocytosis (HLH) following CAR-T cell therapy, Schnitzler syndrome, and macrophage activation syndrome (MAS).
- Policy
- Empagliflozin, linagliptin see sharp price drops amid generic entry
- by Jung, Heung-Jun Feb 20, 2026 10:04am
- The weighted average prices of diabetes drugs empagliflozin and linagliptin plummeted by as much as 34% after patent expiry due to generic penetration.For empagliflozin 10mg, the weighted average price stood at KRW 618 two years ago but fell to KRW 408 last year, reflecting significant downward pressure from generic competition.According to a comparison of the 2025 annual weighted average prices by active ingredient, released by the Health Insurance Review & Assessment Service (HIRA), with 2024 figures, empagliflozin and linagliptin recorded notable price reductions.Statin+ezetimibe combination therapies also posted weighted average price declines of 1–3% across strengths. AI-generated image.Additionally, the weighted average prices of other dyslipidemia combinations, such as atorvastatin + ezetimibe and rosuvastatin + ezetimibe, also decreased slightly. While the reduction rate is lower than that of diabetes drugs, at around 3%, the financial impact remains substantial given the large prescription volumes.The patent expiry of Jardiance triggered a surge of generic launches, significantly reducing empagliflozin’s weighted average price. In 2024, empagliflozin 10mg and 25mg were priced at KRW 618 and KRW 798, respectively, but fell to KRW 408 and KRW 532 last year.Linagliptin followed a similar trajectory after patent expiry of Trajenta, with expanding generic competition driving weighted average price erosion. The weighted average price for linagliptin 5mg fell 23.7%, from KRW 523 to KRW 399.Salt-modified products, including linagliptin besylate, also recorded parallel reductions. The weighted average price, which was KRW 525 in 2024, decreased by 23% to KRW 402 last year.Dyslipidemia combination drugs showed relatively smaller declines. The weighted average prices of statin+ezetimibe combinations decreased slightly.For example, the weighted average price of atorvastatin 80mg + ezetimibe 10mg decreased from KRW 1,387 to KRW 1,340, a 3.4% drop. Rosuvastatin 2.5mg + ezetimibe 10mg decreased from KRW 696 to KRW 670, a 3.7% drop.The statin + ezetimibe market is worth approximately KRW 1.4 trillion, and due to the large volume of prescriptions, even a single-digit percentage decrease results in a significant reduction.Despite the slight decline in the weighted average price, the statin + ezetimibe market continues to grow. This indicates that prescription volumes are increasing sufficiently to offset the price declines.
- Policy
- Will the generic drug price cut be put on hold?
- by Lee, Jeong-Hwan Feb 20, 2026 10:03am
- The Ministry of Health and Welfare (MOHW) has decided to exclude the proposed drug pricing reform plan, which includes price reductions for already listed generics, from the agenda of the Health Insurance Policy Deliberation Subcommittee meeting scheduled for today (20th), drawing attention to the rationale behind the move.With the reform proposal removed from the subcommittee agenda, it is also expected to be excluded from the February HIPDC meeting set for the 25th.Observers suggest the ministry deferred subcommittee review to gather additional industry opinions, following strong opposition from the pharmaceutical industry against the Ministry's plan to significantly lower the generic drug price calculation rate from 53.55% to the 40% range.Originally, the Ministry planned to approve the broad framework of the drug pricing system reform plan at this month's HIPDC meeting, targeting implementation in July this year.However, the Ministry appears to have excluded the drug pricing system reform plan from the February subcommittee agenda to gather additional opinions, following strong opposition to the price reduction policy from an emergency counterresponse committee comprising 5 major organizations - Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association (KoBIA), Korea Pharmaceutical Traders Association (KPTA) , Korea Drug Research Association (KDRA), and Korea Pharmaceutical Industry Cooperative (KPICO).As a result, the timeline for subcommittee review of the reform plan is effectively delayed by approximately one month. During this period, the domestic pharmaceutical industry is expected to actively engage in negotiations with the Ministry of Health and Welfare for potential revisions.The industry argues that the Ministry's excessive generic drug price reduction rate undermines investment momentum for new drug R&D, encourages the production of low-quality generics, exacerbates employment instability, and ultimately collapses the pharmaceutical industry.The scale of future conflict surrounding the drug price reduction administration will likely depend on how much and how the Ministry of Health and Welfare accommodates the industry's opinions.A representative from domestic pharmaceutical company A commented, “We understand the Ministry excluded the item from February's deliberation agenda to gather sufficient opinions. Since the implementation date is set for July, the key question is whether the public and private sectors can agree on concrete revisions beyond simply excluding the item.”A representative from domestic pharmaceutical company B said, “Given the pharmaceutical industry's growing resistance, it would have been difficult for the Ministry to unilaterally push through the drug price reduction plan as scheduled. But delaying the deliberation once has little effect in quelling substantial industry backlash. What is needed now is policy action that genuinely reflects on-the-ground realities.”
