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- 2026-04-04 15:20:52
- Policy
- Max ICER for cancer drugs exceeds KRW 50 million
- by Jung, Heung-Jun Jan 09, 2026 08:36am
- As a result of cost-effectiveness evaluations of drugs submitted for economic assessment, the median incremental cost-effectiveness ratio (ICER) for anticancer drugs has remained relatively stable at around KRW 40 million over the past 10 years.However, over the last four years, the maximum ICER has exceeded KRW 55 million, suggesting that the ICER threshold is declining depending on the drug.According to the 'Cost-effectiveness results of drugs submitted for pharmacoeconomic assessment' released by the Health Insurance Review and Assessment Service (HIRA) on January 8, the median ICER for anticancer drugs has not fluctuated significantly, even after the acceptance limits were raised in 2014.Median ICER values for anticancer drugs: The median ICER for anticancer drugs from 2014 to 2021 was KRW 45.32 million. For the 2018–2022 period, it was KRW 39.99 million; for 2019–2023, KRW 39.93 million; and for 2020–2024, KRW 42.94 million.Since 2022, HIRA has announced the median, minimum, and maximum ICER values for general drugs, anticancer drugs, and orphan drugs across four reporting cycles.The median ICER for anticancer drugs from 2014 to 2021 was KRW 45.32 million. For the 2018–2022 period, it was KRW 39.99 million; for 2019–2023, KRW 39.93 million; and for 2020–2024, KRW 42.94 million.overlapping periods, the median ICER for anticancer therapies is consistently in the low-to-mid KRW 40 million range.Notably, the maximum ICER value, which had never previously exceeded KRW 50 million, surged to KRW 55.36 million in the 2020–2024 data. This suggests that the authorities are flexibly recognizing the cost-effectiveness of essential anticancer drugs and strengthening coverage.Maximum ICER values for anticancer drugs.The anticancer ICER data for 2020–2024, announced last month, covers eight active ingredients. The drugs that broke through the KRW 50 million ceiling are likely those subject to 'flexible threshold application,' such as Enhertu or Trodelvy, before and after innovative ICER standards were introduced.Given the timing and pricing, Enhertu, a targeted therapy for breast cancer, appears to be the most likely candidate for the record-high maximum value.Upward trend of ICER values over the past decade is also observed in orphan drugs. Specifically, the minimum ICER for rare disease drugs has increased sharply. This reflects the growing prevalence of high-priced orphan drugs compared to the past.The minimum ICER for rare disease drugs rose from KRW 23.16 million (2014–2021) to KRW 39.97 million (2020–2024). The cost-effectiveness of orphan drugs is now approaching KRW 40 million, with a strong upward trajectory.In the 2020–2024 ICER evaluation results, the median for orphan drugs was not disclosed because it included only three rare disease drug active ingredients, which could have led to the identification of specific products.
- Company
- Atopic dermatitis drug 'Ebglyss' enters tertiary hospitals
- by Eo, Yun-Ho Jan 09, 2026 08:36am
- Ebglyss (lebrikizumab)'Ebglyss,' a new atopic dermatitis treatment, has entered the 'Big 5' tertiary generic hospitals.According to industry sources, Lilly Korea's interleukin (IL)-13 inhibitor Ebglyss (lebrikizumab) has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital, as well as medical institutes, including Korea University Anam Hospital and Seoul National University Bundang Hospital.After Ebglyss was included in the insurance reimbursement listing in July, the prescription areas for this drug have expanded rapidly.Ebglyss is a new biologic that selectively blocks cytokine IL-13, a primary cause of atopic dermatitis. Ebglyss was approved in August 2024 for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older (weight over 40kg) who are not adequately controlled by topical therapies or for whom these therapies are not recommended.Existing atopic dermatitis treatments include Dupixent, which inhibits IL-4 and IL-13, JAK inhibitors like Rinvoq, and Adtralza, which targets IL-13. The emergence of Ebglyss further expands the range of treatment options. As atopic dermatitis is a chronic disease that is difficult to cure and requires long treatment periods, a wide range of therapeutic options is essential.The efficacy and safety of Ebglyss have been confirmed through Phase 3 clinical studies, including ADvocate-1, ADvocate-2, and ADhere.In ADvocate-1 and ADvocate-2, which evaluated Ebglyss monotherapy, the Ebglyss group showed Eczema Area and Severity Index (EASI)-75 rates of 58.2% and 52.1%, respectively, during the induction period (weeks 0-16), representing an improvement over the placebo group (16.2% and 18.1%). EASI-90 rates for the Ebglyss groups were 38.3% and 30.7%, respectively, while placebo groups remained at 9% and 9.5%. EASI is the percentage improvement in eczema severity.Furthermore, after one year of maintenance therapy, the Ebglyss group's EASI-75 achievement rate at week 52 was 81.7%, and the EASI-90 rate was 66.4%. These figures were higher than those of the placebo group, at 66.4%.According to Korea's atopic dermatitis guidelines, systemic treatment is strongly recommended for patients with moderate-to-severe atopic dermatitis. However, while the proportion of moderate-to-severe atopic dermatitis patients in Korea increased from 30.9% to 39.7% between 2002 and 2019, the prescription rate of systemic immunosuppressants in this patient group remained at only 5%.
- Company
- Rep. Soo-jin Choi, ‘Why lower drug prices for usage increases?’
- by Kim, Jin-Gu Jan 09, 2026 08:36am
- Rep. Soo-jin Choi of the People Power Party (member of the National Assembly’s Science, ICT, Broadcasting and Communications Committee) sharply criticized the price-volume linkage system at the pharmaceutical industry’s New Year reception.She pointed out that a structure lowering drug prices solely because usage increased is far removed from alleviating the public's medical expense burden and could instead undermine the supply base for generic drugs and the foundation of Korea’s pharmaceutical and biotech industry.Choi made these remarks while delivering a New Year's address at the 2026 Pharmaceutical New Year's Reception hosted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on the 7th. She began, “I'd like to take this opportunity to say this. I still don't understand why drug prices are linked to usage volume.”She continued, “The drugs that can be supplied to the public without burden are affordable generics. New drugs, on the other hand, are truly expensive. Setting generic drug prices below KRW 100 is essentially telling manufacturers not to produce them.”She also assessed that the price reduction tied to increased usage is overly driven by fiscal logic.Choi criticized, “Lowering prices even for medicines whose increased usage allows them to be supplied more affordably to the public is an approach that looks only at numbers and National Health Insurance finances.”She emphasized, “If the industry cannot develop solely because of fiscal consolidation, the Korean pharmaceutical industry will ultimately lose its competitiveness. Drug price reductions must be approached very cautiously and from a holistic perspective.”Regarding institutional reform, she urged the government to conduct a thorough review, adding, “It is time to form an expert panel and build a realistic system that allows high-quality medicines to be supplied to the public at appropriate prices.”
- Company
- Diverging views on pricing reform surface at New Year gathering
- by Kim, Jin-Gu Jan 09, 2026 08:36am
- The 2026 Pharmaceutical New Year's Reception was held with the attendance of approximately 200 key figures from the government, National Assembly, and pharmaceutical industry. Amidst New Year's greetings and presentations of industry visions, differing perspectives on the government's ongoing drug pricing system reform were once again evident throughout the event.The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and the Korean Pharmaceutical Association (KPA) expressed concerns about the potential industrial impact and on-site confusion resulting from the drug pricing system reform. In contrast, the government and ruling party reaffirmed the fundamental direction of the drug pricing system reform and stated their commitment to pushing forward its implementation.In his welcome address, KPBMA Chair Yunhong Noh identified the drug pricing reform as a pending issue that may seriously affect the entire industry.Noh stated, “The drug pricing system reform is an issue that could shake the very foundation of Korea's pharmaceutical and biotech industry. Rather than pushing ahead the government's set schedule, the reform must be redesigned through consultation with industry stakeholders to strike a balance between public health, industrial growth, and pharmaceutical expenditure.” His remarks were interpreted as a clear call for adjusting the pace of reform and supplementing or recalibrating the system.The Korean Pharmaceutical Association also expressed concern over confusion in the field. Young-hee Kwon, President of the Korean Pharmaceutical Association, said, “Large-scale drug price cuts implemented earlier this year are expected to cause significant confusion across pharmacies. To reduce recurring confusion and improve policy effectiveness, the government must prepare clear institutional alternatives. Practical adjustments are necessary, such as addressing inventory claims and settlement issues.”The Ministry of Health and Welfare explained the direction of the drug pricing system reform as ‘rewarding innovation and ensuring stable supply,’ and reaffirmed its commitment to continue the push.Hyung-hoon Lee, Vice Minister of Health and Welfare, stated, “We will pursue improvements to the drug pricing system to sufficiently reward the value of innovation and ensure the stable supply of essential medicines. We will support the pharmaceutical and biotech industry’s evolution into a more innovation-oriented ecosystem.”Meanwhile, Yu-kyoung Oh, Minister of Food and Drug Safety (MFDS), pledged regulatory support amid a changing regulatory environment. Oh said, “This year will mark the first year of a major transformation in pharmaceutical regulatory services. We will increase the speed and efficiency of reviews by expanding review personnel and introducing an AI-based review support system.”Ruling party lawmakers largely defended the policy direction of drug pricing reform.Yoon Kim, a lawmaker from the Democratic Party of Korea, emphasized, “Drug pricing reform should not be viewed simply as a policy aimed at cutting prices to reduce National Health Insurance spending. It is part of a broader effort to transform the pharmaceutical and biotech industry into an innovative ecosystem that has global competitiveness.”Kim added, “Of course, I am fully aware that there are significant concerns raised in the field. However, if we share the common goal of elevating Korea's pharmaceutical industry to a global level, we can sufficiently discuss and adjust the pace and details of the system. At the National Assembly level, we will reflect the voices from the field and play our role to ensure that the drug price adjustment policy leads to industrial innovation.”Rep. Young-seok Seo, also of the Democratic Party of Korea, remarked, “While various institutional challenges exist, the ultimate criterion for judgment is the public's right to health. We must find solutions within the broader framework of public health.”Opposition lawmakers were generally more critical of both the current pricing system and the government’s reform direction.Rep. Soo-jin Choi of the People Power Party, referring to the price-volume linkage system, pointed out, “The drugs that can be supplied to the public without burden are affordable generics. Setting generic drug prices below KRW 100 is effectively telling manufacturers not to produce them.”Choi further emphasized, “Lowering the price of drugs that can be supplied more cheaply to the public simply because they are high-volume is an approach focused solely on numbers and the NHIS budget. If industry development is sacrificed solely for fiscal soundness, Korea’s pharmaceutical industry will ultimately lose competitiveness. Drug price reductions must be approached very cautiously and from a comprehensive perspective.”Rep. Jia Han of the People Power Party also emphasized, “The system cannot outperform reality on the ground,” calling for system design that reflects industrial realities. Rep. Joo-yeon Lee of the Reform Party also expressed concern, stating, “Without concurrent regulatory improvements and creation of an investment-friendly environment, we risk falling behind in global competition.”There was also discussion of international non-proprietary name (INN) prescribing and generic substitution. KPA President Kwon noted that an amendment to the Pharmaceutical Affairs Act, which simplifies post-notification requirements for substitution, has passed the National Assembly and is scheduled to take effect in February. It has been a long-standing aspiration since the introduction of the drug dispensing separation system.”Kwon also cited specific figures regarding INN prescribing, stating, “According to research by the Korea Institute for Pharmaceutical Policy Affairs, INN prescribing could generate total savings of KRW 9 trillion, including drug costs and broader social costs.” She added that public consensus and media attention on INN prescribing are growing.Rep. Young-seok Seo mentioned the legislative progress on generic substitution, noting that “some long-standing goals of public-sector pharmacists, including the generic substitution simplification law and pay raises, have been partially achieved.” However, regarding the broader system, Seo added that “many challenges still remain.”
- Policy
- AZ’s gMG candidate ‘gefurulimab’ receives GIFT designation
- by Lee, Tak-Sun Jan 09, 2026 08:36am
- AstraZeneca's ‘gefurumab,’ its new drug candidate for myasthenia gravis, has been selected for fast-track review support by Korea’s Ministry of Food and Drug Safety (MFDS).This designation is expected to accelerate its commercialization.On the 5th, the MFDS announced that AstraZeneca’s gefurulimab had been designated as the 63rd product under the GIFT (Global Innovative product on Fast-Track) program.GIFT is a fast-track review program operated by the MFDS since September 2022 to provide patients with new treatment opportunities through expedited product development support.Products eligible for GIFT designation include drugs for life-threatening diseases, rare diseases with no existing treatment alternatives, and innovative new drugs developed by certified innovative pharmaceutical companies.The MFDS designates GIFT products through a comprehensive evaluation of factors such as innovative therapeutic benefit, contribution to public-health crisis response, and the developer’s R&D efforts.Selection into GIFT reduces the review period by at least 25% (from 120 working days to 90 working days).This is achieved by applying a rolling review process, where submitted data are reviewed first, and close communication between reviewers and developers, which is facilitated through product briefings and supplementary explanations. Additionally, companies receive various supports for rapid commercialization, such as specialized regulatory consulting.AstraZeneca announced positive results last July from the Phase III PREVAIL trial, which evaluated the use of gefurulimab in adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). Gefurulimab met the primary endpoint and all secondary endpoints in the trial.Gefurulimab is a terminal complement inhibitor that selectively binds to both complement protein C5 and serum albumin. It is a novel bispecific nanobody drug candidate optimized for self-administered subcutaneous injection to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG).Generalized myasthenia gravis is a chronic autoimmune neuromuscular disorder, a rare disease causing muscle function loss and severe muscle weakness.Gefurulimab has been favorably evaluated for its convenience, as it allows once-weekly self-administration, compared with existing treatments for adult myasthenia gravis, such as Ultomiris and Soliris.AstraZeneca Korea's status as a Korean Innovative Pharmaceutical Company influenced gefurulimab’s selection for the GIFT program.This drug has not yet received approval from advanced overseas regulatory agencies such as the US FDA, Europe’s EMA, or Japan’s PMDA. The Ministry of Food and Drug Safety (MFDS) applied its fast-track review program ahead of these overseas agencies.However, the US FDA has designated this drug as an orphan drug and is providing support. The MFDS also designated this drug as a development-stage orphan drug this month.To date, 49 of the drugs designated as GIFT have received marketing authorization.
- InterView
- [Reporter's View] CES 2026, Physical AI and utility task
- by Hwang, byoung woo Jan 08, 2026 07:31am
- One of the keywords from CES 2026, which opened in Las Vegas on January 6 (local time), was 'Physical AI.'As the world's largest tech exhibition, CES serves as a global stage for emerging trends in AI, digital healthcare, mobility, and smart homes.This year at CES, the primary themes in the medical sector were Medical AI with high clinical usability, automation-based diagnostic technologies, and innovations in women's health.While CES is intended to be a forum for the future of technology, this focus was even more pronounced this year.In this year's keynote, Nvidia put Physical AI at the forefront, emphasizing a flow of "Executable AI" spanning robotics, autonomous driving, and manufacturing. Even within the medical and healthcare sectors, Nvidia explained its utility cases in terms of products and partnerships rather than mere theoretical models.This shift is most visible in the digital health sector. CES designated digital health as a major pillar of its official programming.According to KOTRA analysis, the digital health sector saw a 7.4% year-over-year increase in participating companies, the highest growth rate among all industry groups at CES 2026.The term 'expansion' was also officially highlighted, with CES organizers noting that 2026 digital health programming would broaden to include women's health, AI, and wearables.However, the discussions surrounding Physical AI presents a new set of challenges for the domestic medical device industry, which has centered itself around digital health. The center of gravity is shifting from technological performance to the practical role played on-site.The industry is no longer satisfied with AI that proves its validity in research papers. It now demands evidence of how much it reduces bottlenecks in hospital workflows, cuts operating costs, and saves labor and time, ultimately translating these results into contracts.Digital health has long grown by "borrowing time from the market" under the guise of innovation. However, in the era of Physical AI, the market is asking whether that innovation can fundamentally alter cost structures and redesign daily clinical workflows.In this context, it is consistent with Lunit's position as an industry leader that has expanded its reach through global market share gains and strategic M&A that it continues to receive questions regarding its break-even point (BEP).This is not a task for any single company. The entire 'K-Medical Device' sector is expected to face a reality where medical software must integrate with hardware to prove tangible economic utility. For technology to become a reality, it must ultimately reach patients and medical professionals. The collaboration model recently demonstrated by Seers Technology and Daewoong Pharmaceutical is highly suggestive in this regard. A venture company with technical capacity, leveraging the robust sales network and trust of a traditional pharmaceutical firm to overcome the conservative barriers in the medical field, will be linked to future revenue demands.The question posed by CES 2026 is clear. Digital healthcare must now prove it is a tangible industry capable of generating revenue, overcoming its status as a mere 'future growth engine.'
- Company
- Multiple sclerosis drug Ocrevus lands in Big 5 Hospitals
- by Eo, Yun-Ho Jan 08, 2026 07:31am
- The new multiple sclerosis (MS) drug Ocrevus (ocrelizumab) may now be prescribed at top tertiary hospitals in Korea.According to industry sources, Roche Korea’s relapsing multiple sclerosis (MS) drug Ocrevus (ocrelizumab) has passed drug committee (DC) reviews at major medical institutions nationwide, including Korea’s “Big 5” general hospitals: Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Severance Hospital.Since its reimbursement listing in March 2025, Ocrevus has rapidly expanded its prescribing base. With the recent domestic approval of a subcutaneous (SC) formulation, its influence in the MS treatment landscape is expected to continue to grow further.Ocrevus targets CD20-expressing B cells that affect the demyelinating process that causes neurological disorders in MS patients.MS is a chronic disease in which myelin is damaged by an autoimmune inflammatory response. Damage to the myelin sheath causes symptoms such as muscle weakness, fatigue, and vision impairment, and can lead to non-traumatic disability. As of 2022, an estimated 2,674 patients in Korea are known to be suffering from MS, with those in the 20s to 40s age group accounting for more than 62% of the total patient population.Antibody therapies such as Tysabri (natalizumab), Gilenya (fingolimod), and Mabthera (rituximab) have been used for the disease, but there has been a persistent call for additional high-efficacy drugs.Various new drugs have been developed overseas, including Novartis' Kesimpta (ofatumumab) and TG Therapeutics' Briumvi (ublituximab), but Roche's Ocrevus is the only one introduced in Korea.Ocrevus also offers an advantage in dosing convenience. Ocrevus can be administered once every 6 months, which is more convenient than Kesimpta (administered once every month).The approval was based on the Phase III OPERA-I and II studies. The studies evaluated the efficacy and safety of Ocrevus versus Biogen's interferon therapy Plegridy (interferon beta-1a) in patients with relapsing MS.In the trial, Ocrevus reduced the annualized relapse rate (ARR) by nearly half compared to Plegridy. Specifically, in the OPERA I study, the ARR was 0.156 for 96 weeks of Ocrevus versus 0.292 for the control arm, and in OPERA II, the ARR was 0.155 for 96 weeks of Ocrevus versus 0.290 for the control arm.Ocrevus also showed efficacy in the Phase III ORATORIO study in patients with primary progressive MS. In this study, Ocrevus reduced the risk of confirmed disability progression (CDP) by 24% over 12 weeks compared to the control group.Ho Jin Kim, professor of Neurology at the National Cancer Center, said, “In MS, even small differences in the early stages can have huge cumulative consequences. This is why the benefits of early access to highly effective therapies are significant. Such treatments will not only improve patients' quality of life but also help reduce the social and economic burden costs. Ocrevus is highly versatile because it has secured sufficient data not only on efficacy but also on long-term treatment administration.”
- Company
- Companies banned from displaying product names on souvenirs
- by Chon, Seung-Hyun Jan 08, 2026 07:31am
- Pharmaceutical companies are now prohibited from displaying product names on promotional material such as pens and notebooks provided to healthcare professionals at product briefing sessions; only the company name may be displayed.According to industry sources on the 7th, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) received Fair Trade Commission approval for the 5th revision of its ‘Fair Competition Code for Pharmaceutical Transactions’ and ‘Detailed Operational Standards for the Fair Competition Code.Among the newly added provisions, the scope of promotional items provided to healthcare professionals has been more clearly restricted.Previously, during product briefings conducted during visits to individual medical institutions, pharmaceutical companies were permitted to provide healthcare professionals with food and beverages, as well as low-value promotional items bearing either the company name or product name.Under the revised rules, companies are now allowed to provide pens and notebooks bearing only the company name strictly for the purpose of delivering medical and pharmaceutical information at on-site briefings. Product names are explicitly prohibited from being printed on these items. Additionally, commemorative gifts may not be provided, and the combined value of the pens and notebooks must fall within the scope of ‘commemorative gifts valued at KRW 50,000 or less’ as specified in the scope of economic benefits permitted under the Enforcement Rules of the Pharmaceutical Affairs Act.The revised code also introduces a new requirement mandating that pharmaceutical companies prepare and disclose an expenditure report detailing economic benefits provided to pharmacists, Korean medicine pharmacists, medical professionals, founders of medical institutions, or employees of medical institutions within 3 months after the end of each fiscal year. Companies must retain the expenditure report, related accounting records, and supporting documentation for 5 years.The definition of pharmaceutical sales promoters has also been expanded. In addition to pharmaceutical suppliers as defined under the Pharmaceutical Affairs Act (i.e., marketing authorization holders, importers, and wholesalers), the scope now explicitly includes “entities entrusted with pharmaceutical sales promotion and those re-entrusted by them.” This clarification means that CSOs (Contract Sales Organizations) acting on behalf of pharmaceutical companies or wholesalers are also subject to the Fair Competition Code's regulations on promotional activities.The revised code also newly stipulates that when pharmaceutical companies support domestic academic conferences or international academic conferences held in Korea, they must not provide any additional financial or in-kind benefits related to the same conference, such as donations, food and beverage offerings, booth rentals, or advertising.New sanctions have also been introduced for companies found to have illegally supported academic conferences.Under the revised provisions, if it is confirmed through a court ruling, administrative action, or investigation by KPBMA that a pharmaceutical company supported the hosting or operation of an academic conference for improper purposes, the Association is prohibited from approving that company’s support for any academic conference hosting or operation for a period of two years from the date the fact of supporting the hosting or operation for improper purposes is confirmed.
- Company
- Prescription drug approvals·BE testing slowing down
- by Chon, Seung-Hyun Jan 08, 2026 07:31am
- The entries of pharmaceutical companies into the prescription drug market continued to slow last year. Approval numbers for new products have dropped by more than 80% compared to six years ago, when generic approvals were at their peak. Creating new revenue streams has become increasingly difficult due to tightened regulatory hurdles, such as restrictions on joint development and the implementation of a tiered drug pricing system. The number of bioequivalence trial approvals related to generic development continues to decline. Concerns are arising that upcoming pricing reforms next year, which will lower generic prices further, may completely extinguish the drive for pharmaceutical companies to enter new markets.Number of prescription drug approvals dropped 82% compared to 6 years ago...generic launch slowed down due to strengthened regulations of approvals and drug pricingAccording to data released by the Ministry of Food and Drug Safety (MFDS) on January 6, 747 prescription drugs were approved last year. There is a 29% increase from the 579 approvals in 2024, but this is an 18% decrease compared to the 915 approvals in 2023.The number of prescription approvals dropped by 33% over the past three years, from 1,118 approvals recorded in 2022.The downward trend has continued since approvals fell 38% from 4,195 in 2019 to 2,616 in 2020. Comparing last year's figures to 2019, the volume of prescription drug approvals has diminished by 82% in just six years.Number of prescription drug approvals by month (unit: number, source: MFDS)Industry analysts believe this slowdown in new generic entries has become solidified due to shifts in pricing and approval systems.Since July 2020, a tiered pricing system has been in implemented, where the ceiling price decreases the later a product is listed for reimbursement. If more than 20 generics of a specific ingredient are already listed, new entries can only receive a ceiling price as low as 85% of the existing lowest price. Furthermore, unless a pharmaceutical company develops the generic internally and conducts its own bioequivalence trials, the price drops significantly. This structure has led to a sharp decrease in approvals for generics that rely on contracted manufacturing.Higher regulatory approval barriers have contributed to diminished drive to market entries. Following the implementation of reform to the Pharmaceutical Affairs Act in July 2021, the number of incrementally modified drugs and generics that can be approved based on a single clinical trial has been limited. The new regulation, the so-called '1+3' rule, limits the number of incrementally modified drugs and generics that can be approved based on a single clinical trial. Specifically, a company that conducts its own trial can only share its data with three other products. Previously, multiple companies could receive approval for 'consigned generics' using the same data set. This regulation effectively made it impossible for 'unlimited generic replication.'The number of prescription drug approvals has shown robust growth since 2018, followed by a steady decline after 2020.In 2018, 1,562 prescription drugs were approved, averaging 130 per month. This figure surged more than twofold in 2019 to 4,195 approvals, or an average of 350 per month. In May 2019 alone, the number of approvals reached 584.From October 2018 to July 2020, over 100 prescription drugs were released every month. However, in August 2020, for the first time in 23 months, monthly approvals fell below 100. Following the approval of 216 items in January 2023, the monthly figure has remained below 100 for nearly three years, with the sole exception of July last year, when 118 approvals were recorded.The surge in 2019 and 2020 was attributed by the government’s movement toward stricter regulations. In 2018, 175 hypertension treatments containing the active ingredient valsartan were banned due to excessive impurities. In response, the MOHW and the MFDS formed a 'consultative body to improve the generic drug system' and limit the oversaturation of generics.As the government showed plans for these regulatory tightening measures, pharmaceutical companies moved ahead to secure generic product approvals, leading to a temporary spike. Since the actual implementation of these institutional reforms, the momentum for new market entries has slowed significantly.Bioequivalence trial approvals down 61% from 4 years ago…diminished new entries of generics·underlying effects of drug pricing re-evaluationRecent attempts to conduct bioequivalence trials for generic market entry have also stagnant.Last year, the number of bioequivalence trial plan approvals stood at 199, unchanged from 197 in 2023. This is a sharp decline from the 505 approvals recorded in 2021. Compared to four years ago, attempts at bioequivalence trials have decreased by 61%.On the surface, new generic entry attempts by pharmaceutical companies have significantly decreased. Industry experts diagnose this as a result of a lack of major generic market openings and the loss of momentum for latecomers following the implementation of the tiered drug pricing system.Number of bioequivalence testing plan approvals by year (unit: number, source: MFDS)The recent decline also reflects an underlying effect from the conclusion of the government's generic price re-evaluation.In June 2020, the Ministry of Health and Welfare (MOHW) announced a plan to re-evaluate pharmaceutical ceiling prices, maintaining existing prices only for generics that submitted proof of internal 'bioequivalence testing' and the use of 'registered drug master files (DMF)' by early 2023.The generic drug price re-evaluation is a policy that applies the new pricing system, which took effect in July 2020, to previously listed generic products. Under the reformed system, a generic product can receive the maximum price only if it meets both criteria, outlining that the manufacturer must conduct its own bioequivalence trial and use registered drug master files (DMFs).To avoid price cuts, pharmaceutical companies launched bioequivalence trials for generics that had already received approval. This strategy involved reformulating existing generics, conducting trials to prove equivalence, and obtaining modified approvals to maintain their current pricing. A common tactic was to switch from outsourced manufacturing to in-house production, thereby satisfying the 'conducted bioequivalence trial' requirement to evade price reductions.Consequently, approvals for bioequivalence trial plans, which recorded at 259 in 2019, rose by 24.7% to 323 in 2020 following the announcement of the re-evaluation. By 2021, this number doubled to 505 cases in just two years. Analysts suggest that with the conclusion of the price re-evaluation, the unusual phenomenon of conducting trials for already-approved generics has vanished, causing trial approval numbers to return to a downward trend.Pharmaceutical companies have already experienced significant losses due to these re-evaluations. In September 2023, the first round of generic price re-evaluations resulted in price cuts of up to 28.6% for 7,355 items. In March 2024, a second round saw prices for 948 items drop by as much as 27.9%. Additional cuts were also imposed on newly categorized products that require equivalence testing, such as sterile preparations like injectables.Pharmaceutical companies anticipate that another reform of the pricing system this year will further dampen market entry.In the reform scheduled for this July, the calculation base for generic prices is expected to drop from 53.55% of the pre-patent-expiration price of the original drug to the 40% range, with 40%-45% as the most likely target. Mathematically, if the maximum generic price falls from 53.55% to 40%, it represents a 25% deterioration in profitability.Entry barriers to late-stage generics are expected to rise as the government increases penalties for failing to meet maximum price requirements.Under the July 2020 reform, a generic price is reduced by 15% for each criterion not met. If both are not met, the price is cut by 27.75%. Currently, failing one criterion drops the 53.55% base to 45.52%, and failing both drops it to 38.69%.Under the upcoming reform, the reduction rate for failing a criterion will increase from 15% to 20%. If the new base is set at 45%, a generic failing one requirement will drop to 36%, and one failing both will fall to 28.8%. If the base is set at 40%, these figures drop further to 32.0% and 25.9%, respectively. In this scenario, a generic failing one requirement would see its price reduced by 20.9% compared to current levels. A generic failing two requirements would see its price reduced by 25.6%.If the criteria are set to 40% , a generic that relies on contracted manufacturing without conducting its own bioequivalence trial would be capped at 32.0% of the original drug's pre-patent price. This is a 29.7% decrease from the current 45.52%. Compared to the era before the 2020 ceiling price requirements were introduced, generic prices would be cut by more than 40% (from 53.55% to 32.00%). For those failing both requirements, the cap would be 25.6%, a 33.8% drop from the current 38.69%.The drive for latecomers to enter the market is expected to shrink further as the tiered pricing system is strengthened. The MOHW has proposed a plan to apply five percentage-point reductions, starting with the 11th generic entry of the same formulation, a significant tightening from the current 21st-entry regulation. Under the reformed system, this additional price cut measure will trigger much earlier, effectively lowering price standards across the entire generic sector.
- Policy
- Plan to waive Phase 3 for comb therapies for HTN and DYS
- by Lee, Tak-Sun Jan 08, 2026 07:31am
- Ministry of Food and Drug Safety (MFDS)The Ministry of Food and Drug Safety (MFDS) has announced an exemption for Phase 3 clinical trials of combination therapies targeting hypertension and dyslipidemia, provided the components do not mutually interfere with efficacy or safety. This exemption is also expected to extend to triple-combination therapies that include diuretics.However, the MFDS explained that Phase 3 data will be waived only if meta-analysis data confirm that treatments for hypertension and dyslipidemia do not affect each other’s therapeutic effects or safety profiles.The MFDS has prepared a revision to the 'Guidelines for Clinical Trials of Combination Drugs' and is collecting industry feedback through January 13.The new addition outlines a plan to rationalize data submission requirements for developing combination drugs intended for comorbid conditions, organized in a Q&A format within the guidelines.According to the guidelines, the MFDS stated, "Regarding combination drugs for the treatment of comorbid hypertension and dyslipidemia, we have determined that therapeutic confirmatory clinical trials (Phase 3) can be exempted for specific drug classes based on the results of meta-analysis performed on accumulated domestic clinical trial data."The MFDS added, "To date, hypertension + dyslipidemia combinations developed in Korea have primarily consisted of ARBs (Angiotensin II Receptor Blockers) or CCBs (Calcium Channel Blockers) for hypertension, and Statins or Ezetimibe for dyslipidemia," and explained," Meta-analysis of previously submitted clinical results indicate that these hypertension and dyslipidemia treatments do not mutually affect therapeutic efficacy or safety."Based on these findings, the MFDS has finalized a policy to exempt therapeutic confirmatory clinical trial data for companies developing combination drugs composed of ARB or CCB and Statin or Ezetimibe. Nevertheless, the MFDS noted that even within these classes, toxicological patterns or pharmacokinetic profiles may vary by specific active pharmaceutical ingredient (API).The MFDS explained that a therapeutic confirmatory clinical trial may be requested in some cases because the toxicity profile and pharmacokinetics may vary depending on APIs. The MFDS stated, "Developers must present a review of the impact on safety and efficacy based on trial data regarding absorption, distribution, metabolism, and excretion (ADME), as well as pharmacokinetic drug-drug interaction studies," the MFDS added. "If significant drug-drug interactions are observed in pharmacokinetic studies and are judged to potentially affect safety or efficacy, a therapeutic confirmatory clinical trial may be requested."Regarding triple-combination drugs that include a diuretic in addition to these two components, the MFDS explained that while Phase 3 data submission is the general rule, exemptions are possible under specific conditions.The MFDS stated, "For hypertension-dyslipidemia combinations containing drugs in addition to the mentioned classes (e.g., diuretics), therapeutic confirmatory clinical trials must be submitted as before. However, if meta-analysis data for the specific drug class being developed confirms that the hypertension and dyslipidemia treatments do not influence each other's efficacy and safety, the requirement for Phase 3 data may be waived."In cases where the combination includes a new drug ingredient or involves changes to dosage and administration, additional safety and efficacy data will be required. The MFDS advised, "If a new drug is included in the proposed combination or if it deviates from the approved labeling (dosage, administration, etc.) of the individual treatments, additional safety and efficacy evaluations may be necessary," and added, "We encourage companies to consult with the Ministry in advance."
