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- 2026-03-10 05:36:44
- Policy
- “What we need is competition, not rebates”
- by Lee, Jeong-Hwan Jan 28, 2026 08:12am
- “Stop the meaningless debate on what percentage the government is willing to adjust the generic drug calculation rate. Lowering drug prices will simply increase prescription volume, so it won't lead to savings in drug expenditures. The government must regulate rebates to create an environment where lower-priced drugs are prescribed more frequently. That's how we achieve savings in the national health insurance budget.”Academic experts view that lowering generic drug reimbursement rates alone, even if the government reduces the generic pricing formula from 53.55% to the 40% range, will not lead to savings in the National Health Insurance (NHI) budget.In other words, simply lowering the generic drug calculation rate, which has led to repeated battles between the MOHW and the industry, will not lead to actual drug cost savings. Rather, the government should focus on eliminating illegal rebates and establishing a market-driven drug pricing environment to save the National Health Insurance and foster the growth of the domestic pharmaceutical industry.At a National Assembly policy forum on drug pricing reform held on the 26th, Professor Hye-young Kwon of the Department of Health Administration at Mokwon University said, “Creating an environment where lower-priced, cheaper drugs are more widely prescribed in the market is what will save NHI finances.”According to Kwon, the ongoing standoff between the government and the pharmaceutical industry over generic pricing percentages will not translate into actual reductions in pharmaceutical expenditure.Kwon also expressed “serious concern” on how the MOHW’s drug pricing reform proposal was announced without sufficient social consensus or prior consultation with stakeholders in the pharmaceutical industry.She further stated that discussing NHI fiscal sustainability solely through adjustments to generic pricing formulas is inherently unreasonable and significantly ineffective.Her logic is that even if the generic drug price calculation rate is drastically lowered from 53.55% to 40%, the amount of drugs prescribed in the market will increase substantially due to lower prices. Consequently, the NHI funds spent on drug costs will remain at the same level before and after the reduction.Kwon advised the Ministry of Health and Welfare that instead of targeting NHIS savings through the generic drug calculation rate, it should devise and implement policies enabling low-cost generics to gain market share. Only then can NHIS savings be successfully achieved.She argued that the current situation, where pharmaceutical companies manipulate prescription volumes through illegal rebates, must be aggressively addressed, stressing the need to create an environment where generics that offer lower prices and higher quality can increase market share.Kwon stated, “There was no social consensus or public deliberation process before the Ministry of Health and Welfare announced the drug pricing system. Personally, it was a very disconcerting announcement. "Reducing health insurance expenditures depends on policies leveraging generics. I find it incomprehensible that they are discussing pricing cuts like lowering the reimbursement rate to the 40% range.““No matter how much you lower generic prices, NHI spending will not decrease. As prices fall, prescription volumes rise proportionally. To date, the MOHW has never successfully reduced healthcare spending through generic pricing policies. Drug prices only fall meaningfully when they are subjected to genuine market competition, guided by the invisible hand.”“The reason Korea has failed to let market forces work is that prescriptions are driven not by lower prices, but by the amount of rebates. The MOHW has failed to establish policies that ensure lower-priced generics gain greater market share, resulting instead in the proliferation of increasingly small-scale, mom-and-pop-style pharmaceutical companies.”“Domestic drug costs are driven by the extremely high prices of off-patent originator drugs. Yet, no advanced country allows originator drugs after patent expiry to generate such high profits. That value should be captured through price competition by domestic generic manufacturers. Only by replacing rebate competition with price competition can Korea simultaneously strengthen its pharmaceutical industry and ensure the long-term sustainability of the national health insurance system.”
- Company
- US tariffs on pharmaceuticals forecast…K-bio closely monitors
- by Chon, Seung-Hyun Jan 28, 2026 08:12am
- U.S. President Donald Trump showed his intent to impose a 25% tariff on pharmaceuticals. Korea's major pharmaceutical companies devised countermeasures by acquiring U.S.-based manufacturing plants. The Korean pharmaceutical industry is also closely watching the continuously changing imposition of tariffs.ChatGPT-generated imageOn January 26, 2026, President Trump posted on Truth Social, "The South Korean National Assembly has failed to implement previously agreed trade measures," adding, "An immediate increase in tariffs on Korean woods, pharmaceuticals, and all other reciprocal goods from 15% to 25%.In October 2025, during the APEC summit in Gyeongju, Korea and the U.S. reached a Most Favored Nation agreement for pharmaceuticals. This deal detailed that tariffs on South Korean medicines would not exceed 15%.According to the details of the agreement disclosed last month, the White House released a South Korea-U.S. Summit Joint Fact Sheet (JFS) that includes an agreement to ensure that tariffs on South Korean pharmaceutical products do not exceed 15%. It was finalized that in any case where tariffs are imposed on pharmaceuticals, the rate will not exceed 15%. For generics, it was decided to apply zero tariffs.The KoreaBIO Association stated, "While it was agreed in the Korea-U.S. trade agreement to apply a maximum of 15% if Section 232 tariffs are applied to pharmaceuticals, it will be difficult to rule out the possibility of a tariff increase to 25% through future amendments to the trade agreement."President Trump has also mentioned the possibility of imposing 100% tariffs on branded pharmaceuticals since October of last year.Through Truth Social on September 25 last year, President Trump stated, "Starting the 1st of next month, a 100% tariff will be imposed on all branded and patented pharmaceuticals from companies that are not building pharmaceutical production plants within the United States." adding, "'IS BUILDING' means a state where groundbreaking has occurred or construction is underway," and "In cases where construction has started, no tariffs will be imposed on the corresponding pharmaceuticals." However, no official tariff measures regarding pharmaceuticals have been announced to date.Korean pharmaceutical and biotech companies with high export volumes to the U.S. are in a state of high alert regarding pharmaceutical tariff rates. Domestic pharmaceutical and biotech companies without local plants in the U.S. have no choice but to closely watch the trend, as U.S. pharmaceutical tariff rates can impact their market penetration.However, it has been suggested that even if tariff rates rise, the direct blow will not be significant for Celltrion and Samsung Biologics, which export the most pharmaceuticals from Korea to the U.S., as they have established countermeasures by acquiring local plants.Celltrion has shown the most preemptive movement in preparation for U.S. tariffs. In September last year, Celltrion's subsidiary, Celltrion USA, signed a formal contract to acquire a biopharmaceutical production plant located in Branchburg, New Jersey, from ImClone Systems Holdings, a subsidiary of Eli Lilly. The acquisition amount is approximately $330 million (about KRW 460 billion). Celltrion received approval from Irish competition authorities in October last year and finally completed the acquisition process in November after the finalization of the business combination review by the U.S. Federal Trade Commission (FTC).Celltrion USA production facility opening ceremony held in June (from left: Kee Woo-sung, Vice Chairman of Celltrion; Todd Winge, CEO of Celltrion Branchburg; Park Kyung-ok, Senior Vice Chairman of Celltrion Holdings; Seo Jung-jin, Chairman of Celltrion Group; U.S. Senator Andy Kim of New Jersey; U.S. Representative Thomas Kean Jr. of New Jersey; Thomas Young, Mayor of Branchburg Township; Seo Joon-seok, Head of Celltrion North America Headquarters).The U.S. production facility acquired by Celltrion is a large-scale campus equipped with a total of four buildings, including production facilities, logistics warehouses, a technical support building, and an operation building on a site of approximately 148,500㎡, capable of producing about 66,000 liters of drug substance (DS). Celltrion plans to enter into an immediate expansion process and invest an additional KRW 700 billion to expand production capacity to a total of 132,000 liters.A Celltrion official explained, "By securing the production facility in Branchburg, New Jersey, we have prepared a fundamental solution regarding tariffs and have structurally escaped from all risks.Samsung Biologics signed a contract last December with GlaxoSmithKline (GSK) to acquire the Human Genome Sciences (HGS) biopharmaceutical production facility located in Rockville, Maryland. This involves an investment of $280 million (approximately KRW 410 billion) by Samsung Biologics America, the U.S. subsidiary of Samsung Biologics, to acquire the plant. The asset acquisition process is scheduled to be completed within the first quarter of this year.View of the Human Genome Sciences biopharmaceutical production facility located in Rockville, Maryland. The Rockville production facility is a drug substance production plant with a total capacity of 60,000 liters located in the center of the Maryland bio-cluster, consisting of two manufacturing buildings. The facility is equipped with infrastructure capable of supporting the production of antibody drugs at various scales, from clinical stages to commercial production.This is Samsung Biologics' first acquisition of an overseas plant. Samsung Biologics operates five plants in Songdo, Incheon. All five plants were constructed using internally procured funds.It appears that biotech companies with large U.S. export volumes have completed preparations for tariff risks by investing a total of over KRW 1 trillion to acquire local plants.According to the Ministry of Food and Drug Safety, South Korea's pharmaceutical export volume to the U.S. in 2024 was $1.49117 billion (approximately KRW 2 trillion), accounting for 16.1% of the $9.28987 billion total export volume of domestically produced pharmaceuticals. Among pharmaceutical exports to the U.S. in 2024, finished pharmaceutical products accounted for $1.29899 billion, or 87.1%, while active pharmaceutical ingredients (API) were only $192.19 million, or 16.9%. Samsung Biologics and Celltrion in the U.S. export of domestically produced pharmaceuticals occupy the most.For Samsung Biologics, U.S. regional sales accounted for KRW 1.1741 trillion, or 25.8% of its KRW 4.5473 trillion total revenue in 2024. Samsung Biologics' U.S. revenue share recorded 28.5% and 26.3% in 2022 and 2023, respectively. Samsung Biologics calculates regional revenue based on the location of its CDMO clients. Samsung Biologics' cumulative U.S. revenue for the third quarter reached KRW 1.6482 trillion, surpassing last year's export volume. U.S. sales accounted for 38.8% of Samsung Biologics' KRW 4.2484 trillion cumulative revenue through the third quarter. For Celltrion, biopharmaceutical sales in the North American market reached KRW 1.0453 trillion in 2024. Celltrion's North American market sales decreased 11.3% from KRW 709.5 billion in 2022 to KRW 629.2 billion in 2023, but increased by 66.1% in 2024 compared to the previous year, surpassing KRW 1 trillion for the first time.
- Company
- New AML drug Vanflyta approved in Korea
- by Son, Hyung Min Jan 28, 2026 08:12am
- Daiichi Sankyo Korea (CEO Jeong-tae Kim) announced on the 26th that its acute myeloid leukemia (AML) targeted therapy Vanflyta (quizartinib) has been approved in Korea.With this approval, Vanflyta can now be used in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation therapy, and as a maintenance mono therapy following consolidation therapy, for adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD-positive.AML accounts for approximately 23.1% of all leukemia cases worldwide, and around 2,000 adults are newly diagnosed with AML each year in Korea. FLT3 mutations are the most commonly reported genetic alterations in AML, with approximately 25% of newly diagnosed AML patients harboring the FLT3-ITD mutation. The FLT3-ITD mutation is associated with a high disease burden and poor prognosis, including shortened overall survival.The efficacy and safety of Vanflyta were evaluated over a long-term period of more than five years in the Phase III QuANTUM-First trial, a randomized, double-blind, placebo-controlled study involving 539 patients with newly diagnosed FLT3-ITD–positive AML.Patients enrolled in the study received induction and consolidation combination therapy followed by up to 3 years of maintenance monotherapy with Vanflyta, regardless of whether they underwent allogeneic hematopoietic stem cell transplantation.Results showed a 22% reduction in the risk of death in the Vanflyta group compared with the placebo group. At a median follow-up of 39.2 months, the median overall survival (mOS) was 31.9 months in the Vanflyta group, an extension compared with 15.1 months in the placebo group.Jeong-tae Kim, CEO of Daiichi Sankyo Korea, stated, “We are very pleased to be able to provide a new first-line treatment option for patients with poor prognosis FLT3-ITD mutation-positive AML with the approval of Vanflyta. Following solid tumors, we are now introducing a therapy that can improve treatment outcomes in hematologic malignancies as well. We will continue our endeavors to make meaningful progress to expand treatment access for more patients in Korea.”Byung-sik Cho, Chair of the Acute Myeloid Leukemia/Myelodysplastic Syndrome Working Group of the Korean Society of Hematology (Professor of Hematology at Seoul St. Mary’s Hospital), said, “Vanflyta has been confirmed to extend both complete remission duration and overall survival when administered as maintenance therapy following induction and consolidation therapy, added to standard chemotherapy in newly diagnosed FLT3-ITD mutation-positive AML patients based on its mechanism that selectively targets the FLT3-ITD mutation. This is expected to bring an important change to AML treatment strategies in Korea.”
- Company
- Rhapsido soon to be launched in Korea
- by Son, Hyung Min Jan 28, 2026 08:11am
- A shift in the treatment landscape for chronic spontaneous urticaria (CSU) is imminent. With Novartis positioning an oral BTK inhibitor as a successor to Xolair, competition over treatment options for antihistamine-refractory patients is entering a new phase.Novartis’s Rhapsido (remibrutinib)According to industry sources on the 28th, Novartis Korea has recently completed its regulatory submission for Rhapsido (remibrutinib). Approval is expected within the first half of this year.Rhapsido is an oral targeted therapy that inhibits Bruton’s tyrosine kinase (BTK), a key pathway in the pathophysiology of CSU, thereby blocking the release of histamine and inflammatory mediators. The drug was approved in the United States last September for the treatment of adult CSU patients whose symptoms persist despite second-generation H1 antihistamines.One of Rhapsido’s most notable features is its oral formulation, taken twice daily. Until now, treatment options for patients unresponsive to first-line antihistamines have been largely limited to the injectable biologic Xolair (omalizumab). The arrival of Rapsido opens a new option, an oral targeted therapy.According to the Phase III REMIX-1·2 clinical trial results, which formed the basis for its U.S. FDA approval, Rhapsido demonstrated superiority over placebo in improving itch severity (ISS7), hive severity (HSS7), and total urticaria activity score (UAS7) starting from Week 2. Approximately one-third of patients achieved complete remission (defined as zero itch and zero hives) by Week 12.In terms of safety, the drug showed a favorable profile, being stable enough not to require laboratory monitoring. Common adverse events were mild and included nasopharyngitis, headache, and abdominal pain.Following the US approval, Novartis has submitted Rhapsido for approval in major markets, including the EU, Japan, and China, where it has received priority review status. With formal submission completed in Korea as well, the entry of the first oral targeted therapy for CSU is imminent.Beyond CSU, Novartis is also expanding clinical development of Rhapsido across a range of immune-mediated diseases, including chronic inducible urticaria (CIndU), hidradenitis suppurativa (HS), food allergy, and multiple sclerosis.BTK inhibitors emerge as a successor to biologics in CSUCompetition in the CSU treatment market is rapidly intensifying around BTK inhibitors.BTK inhibition was first established in hematologic malignancies such as B-cell lymphomas and leukemia. Starting with the first-generation agent Janssen’s Imbruvica (ibrutinib), second-generation drugs BeiGene’s Brukinsa (zanubrutinib) and AstraZeneca’s Calquence (acalabrutinib), and third-generation Lilly’s Jaypirca (pirtobrutinib), have rapidly expanded their market share as later entrants.With the mechanistic advantages of BTK inhibition having also been confirmed in autoimmune diseases, later entrants are increasingly targeting these indications in drug development.Sanofi’s WayrilzNotably, Sanofi is strengthening its BTK inhibitor lineup in addition to its IL-4/13 inhibitor Dupixent (dupilumab).In September last year, Sanofi received US approval for the BTK inhibitor Wayrilz (rilzabrutinib) for immune thrombocytopenia (ITP). The drug has now advanced into Phase III trials for chronic inducible urticaria(CIU) and CSU.While Rhapsido achieves sustained BTK inhibition through irreversible binding, Wayrilz employs a hybrid mechanism combining reversible and irreversible binding.Sanofi is also developing another BTK inhibitor, tolebrutinib. However, development has recently been put to a stop after the FDA issued a Complete Response Letter (CRL).This treatment had garnered expectations for its mechanism of action, which selectively suppresses the immune response in multiple sclerosis by regulating B lymphocytes and disease-associated microglia. However, the requirement for additional data has rendered the approval timeline uncertain.
- Opinion
- [Reporter's View] On downsizing global pharma sales force
- by Son, Hyung Min Jan 27, 2026 06:56am
- The notable change currently observed in the global pharmaceutical industry is a series of organizational restructurings, commonly referred to as Early Retirement Programs (ERP).Major global pharmaceutical companies have already implemented large-scale ERPs centered on sales positions, and the trend of downsizing continues even in traditional areas where sales force strength was historically critical, such as chronic diseases. This trend is similarly impacting the South Korean subsidiaries of multinational corporations.The most apparent reason for this trend is cost efficiency; however, the term "Role Redesign" is increasingly used within these organizations. These adjustments are not intended merely to reduce the workforce; instead, job functions are being restructured as AI-based sales models become fully operational.For several years, global headquarters have been building AI-based systems for visibility optimization, digital channel automation, and prescription-prediction models, while downsizing sales organizations. The information that was previously gathered through field-based sales activities is now presented first by the system, which even recommends specific behavioral strategies.Multinational subsidiaries in Korea and domestic pharmaceutical companies find themselves at a similar crossroads, having reviewed or implemented ERPs in recent years. However, a persistent issue is that ERP in the pharmaceutical sector is still often interpreted as a short-term efficiency measure to improve sales productivity.Global trends indicate that ERP is linked to organizational redesign, job redefinition, and the acceleration of AI and digital transformation. The era where simply reducing staff created efficiency has ended. The more critical question now is which roles should remain.Specifically, the functions of a sales organization are beginning to be divided into tasks AI can perform and those it cannot. The first category includes repetitive and standardized tasks that AI and data can replace. Systems now provide visibility ranking, channel mixes, and basic messaging faster and more accurately than humans.The second category involves high-difficulty roles that AI cannot replace. This includes areas requiring qualitative judgment, such as understanding hospital decision-making structures, regional characteristics, differences in patient distribution, subtle market fluctuations at the time of competing drug launches, and identifying the actual needs of medical professionals.These are the underlying reasons why global firms have expanded Key Account Management (KAM), Hospital Access, and Medical collaboration organizations following their restructurings. Traditional sales are cut down, not strategic sales.As ERP becomes more prevalent in the Korean market, the most significant challenge lies in updating Key Performance Indicators (KPIs) and job standards simultaneously. If an organization implements AI-based strategies but continues to evaluate employees based on legacy metrics, such as the number of visits, simple sales volume, or regional distribution, ERP will only serve to make the organization more inefficient.ERP must be a process of redefining what the organization considers "performance," rather than just adjusting headcount. Immediately following downsizing, global companies transitioned their KPIs to focus on strategy execution, targeting appropriateness, and multi-channel utilization. Conversely, many domestic companies remain tethered to past metrics.Ultimately, ERP is the starting point of change. Whether that change becomes a foundation for new competitiveness or remains a short-term cost-cutting exercise depends on how quickly an organization can redefine roles and standards.In the era of AI, a salesperson's status is determined not by who has accumulated the most data, but by who interprets it correctly. As global restructuring accelerates, pharmaceutical companies must redesign the future of their sales organizations. What remains is more important than what is cut down.
- Policy
- “Drug price reform may bring collapse of generic self-sufficiency”
- by Lee, Jeong-Hwan Jan 27, 2026 06:55am
- Concerns have been raised that if the government’s drug pricing reform, which focuses on generic drug price cuts, is pushed forward without revision, a growing number of domestic pharmaceutical companies will abandon local generic production, ultimately shaking the foundation of Korea's pharmaceutical sovereignty.Critics warn that such an outcome could weaken new drug R&D, increase dependence on overseas sources for both active pharmaceutical ingredients (APIs) and finished drugs, and, in the long run, lead to shortages in domestic generic supply and greater reliance on originator products, making it difficult for the government to achieve its goal of reducing National Health Insurance spending.In particular, as the reform plan announced in late November last year was drafted without sufficient consultation with the pharmaceutical industry, industry experts believe the plan should be revised after ample discussion and then be implemented gradually.On the 26th, attorney Kwan-woo Park of Kim & Chang and attorney Hyun-wook Kim of Shin & Kim (Sejong) outlined the limitations of the Ministry of Health and Welfare’s reform plan and proposed improvements at a National Assembly policy forum on drug pricing reform.“Generics should be viewed as a measure to ensure public access, not merely low-priced drugs”Attorney Park pointed out that the Ministry of Health and Welfare's current drug pricing system reform plan is similar to the 2012 policy of across-the-board price cuts for generic drugs.He noted that although drug expenditure initially declined after the 2012 cuts, spending rebounded to previous levels in just two years. At the same time, production of non-reimbursed drugs, which were not subject to price cuts, increased, employment in the pharmaceutical sector declined, and yet the Ministry appears to be repeating the same administrative mistake it had made more than a decade ago.They expressed concern that if the Ministry pushes through its reform plan without revision, it will lead to a decline in generic drug sales, reduced capacity to maintain production facilities, decreased investment in new drug R&D, and job losses.He also cautioned that increased use of low-cost APIs, such as those sourced from China, could lead to quality deterioration, greater dependence on originator drugs, and the abandonment of generic launches beyond the 11th product for a given formulation, ultimately disrupting the stable supply of finished drugs.Moreover, if the shortage of generic drugs persists and reliance on originator drugs increases, he projected that the achievement of the National Health Insurance Service's cost-saving goals would become uncertain.Park further stated that the other elements of the reform, such as introducing market-linked actual transaction prices, implementing reforms to the reimbursement adequacy reevaluation system, and establishing periodic drug price adjustment mechanisms, cannot escape criticism for reducing predictability for pharmaceutical companies or being redundant or unreasonable regulations.To address the issues with the Ministry of Health and Welfare's reform plan, Park stressed that policies must be established to use generics as a means to strengthen public access to medical care and pharmaceuticals at reasonable prices, and to create measures where generics play a pivotal role in maintaining health security.With regard to the proposed deduction of the generic pricing rate to the 40% range, he urged the Ministry to engage in sufficient consultation with domestic pharmaceutical companies and consider phased implementation or differentiated pricing rates to ease the impact and improve acceptance.Park stated, “Given that the goal of this reform plan is to transform the domestic pharmaceutical industry ecosystem, revisions are necessary to ensure balanced implementation of both expanded incentives for innovative pharmaceutical companies and regulations increasing the discount rate relative to the benchmark drug price. Before implementing the system, the causes of failure in similar systems must be analyzed, and a flexible policy direction must be set to ensure the system becomes effective.”He added, “To mitigate the shock to the domestic pharmaceutical industry caused by immediate sales declines and ensure the system is accepted, the reform must be implemented gradually. Also, meaningful dialogue with the pharmaceutical industry must take place from the design stage.”“France, UK, Japan: Secured governance by gathering pharmaceutical industry opinions when establishing drug pricing policies”Attorney Kim pointed out that the key issue of the Ministry of Health and Welfare's reform plan was that it was unilaterally established and announced without sufficiently gathering opinions from domestic pharmaceutical companies.To minimize opposition from the pharmaceutical industry and increase acceptance of the Ministry's drug pricing policy, the system should be designed based on two-way communication with the industry, rather than a government-only approach. He criticized that Korea failed to sufficiently guarantee the industry's procedural rights by announcing the plan without consultation.In contrast, major countries such as France, the UK, and Japan have established formal consultation procedures and governance structures to incorporate industry input into drug pricing decisions.France has a framework agreement between CEPS, which handles drug price negotiations, and the pharmaceutical industry association. The UK mandates stakeholder participation and operates official public hearings when reforming drug pricing, payment policies, and systems, centered around NHS England and the Department of Health and Social Care.Japan also operates the process for determining and revising drug prices under the National Health Insurance (NHI) system through the Central Social Insurance Medical Council, an advisory committee to the Ministry of Health, Labour and Welfare.Furthermore, Kim also expressed concern that sharply lowering the generic drug reimbursement rate from the current 53.55% to the 40% range would jeopardize the sustainability of the pharmaceutical and biotech industry, threaten public health security, and trigger job losses.Rather than insisting on a 40% pricing ratio, his point is that the Ministry should redesign a reasonable rate through consultation with industry and defer implementation.Kim further suggested strengthening price incentives for companies contributing to supply stability to enhance the reform’s effectiveness in terms of practicality.He proposed guaranteeing a 68% price level for national essential medicines made with domestically sourced APIs, through base pricing rather than a temporary add-on premium, and applying the price premium immediately when companies switch to in-house APIs, rather than waiting until re-listing.He also recommended excluding innovative medicines or products supplied by three or fewer manufacturers from post-listing price cuts and raising the threshold defining low-priced drugs.Kim said, “The reform plan should be revised and implemented only after sufficient discussion is made over an adequate period, ensuring meaningful protection of industry stakeholders’ procedural rights and genuine consultation with the government.”
- Policy
- GOV “Drug price reform needed for industry growth”
- by Lee, Jeong-Hwan Jan 27, 2026 06:55am
- Director Yeon-sook Kim“Korea has an excessive amount of generic products per ingredient. For example, ingredients with annual market sales under KRW 100 billion have an average of 19 approved products; those under KRW 500 billion have 56 products; and those under KRW 1 trillion have more than 100 on average. Given this reality, we need a serious discussion on how to reform the drug pricing system to create growth momentum for the Korean pharmaceutical industry to reach a global level.”Yeon-sook Kim, Director of the Pharmaceutical Benefits Division at the Ministry of Health and Welfare, repeatedly emphasized that the objective of the drug pricing reform is not to reduce National Health Insurance spending, but to encourage new drug development, secure cost recovery for withdrawal-prevention and essential medicines, and strengthen patient access.She expressed that the domestic pharmaceutical industry's claim that the Ministry of Health and Welfare brought up drug price reductions to save NHIS funds is partly based on misunderstanding, urging understanding that the policy goal is a structural reform of the drug pricing system to spur innovation in the pharmaceutical and biotech industries.In particular, Kim pointed out that Korea has an excessively high number of generic products per ingredient and stressed the need for reform of the generic pricing system to stimulate industrial growth.At a policy National Assembly policy forum on the drug pricing system reform held on the 26th, Kim said, “We designed the reform plan with a sense of crisis and concern that the current drug pricing system has reached its limits, unable to guarantee the supply of essential medicines to the public, let alone new drugs.”Kim emphasized that this drug pricing system reform should serve as an opportunity to strengthen patient access to treatments, enhance the stable supply of essential medicines, and boost the innovation capacity of the pharmaceutical industry.In other words, the goal of this drug pricing policy is not merely a cost-cutting overhaul, but rather a fundamental restructuring and improvement of the pharmaceutical industry's foundation.Kim also expressed pride in Korea’s high level of generic self-sufficiency compared to other countries.However, she acknowledged that the current situation, where an excessive number of generics are approved and marketed for each ingredient, needs to be addressed.Ultimately, she argued that adjusting the number of generics per ingredient through the pricing reform is necessary to create momentum for the Korean pharmaceutical industry’s global expansion.Kim offered no specific response or explanation regarding the postponement or modification of the reform plan's implementation.Kim said, “There was a broad drug-price adjustment policy in 2012, but overall drug costs or the absolute amount itself have not declined since then. Given the increase in chronic disease patients, this is natural. The goal of this drug pricing system reform is not to reduce the proportion of drug costs. The goal is to induce structural reform of the pharmaceutical industry.”Kim concluded, “We must also consider that no comprehensive pricing reform has taken place since 2012. Furthermore, given the reality of an excessive number of domestic generic drug items, we must consider a drug pricing system that enables the domestic pharmaceutical industry to expand globally. We will deliberate on which approach is most effective, achieve the desired results, and reflect the realities of the pharmaceutical industry.”
- Company
- Galderma 'Nemluvio' for atopic dermatitis·PN wins nod in KOR
- by Son, Hyung Min Jan 27, 2026 06:55am
- Product photo of NemluvioGalderma Korea (CEO Jaihyuk Lee) announced that Nemluvio (nemolizumab), a biologic that selectively blocks the interleukin (IL)-31 receptor, received domestic approval on the 23rd for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis.With this approval, Nemluvio has become the only treatment option for moderate-to-severe atopic dermatitis that allows the dosing interval to be extended to every eight weeks, reducing the treatment burden on patients by reducing the frequency of administration.Nemluvio is the world's first monoclonal antibody that selectively blocks IL-31 receptor alpha, thereby inhibiting the IL-31 signaling pathway. IL-31 ia primary cause of itching.IL-31 is a neuro-immune cytokine that induces repetitive scratching behavior by directly stimulating nerves and activating sensory neurons that transmit itch signals. In addition to triggering itch, it serves as a quadruple trigger deeply involved in the fundamental pathophysiology of atopic dermatitis and prurigo nodularis, including inflammatory expression, epidermal dysregulation, and skin fibrosis.The basis of Nemluvio approval was the results of the Phase 3 ARCADIA and OLYMPIA clinical trials.ARCADIA 1 and 2 were randomized, double-blind, placebo-controlled, global Phase 3 clinical studies conducted in 941 and 787 patients, respectively, aged 12 and older with moderate-to-severe atopic dermatitis, to evaluate the efficacy and safety of Nemluvio over 48 weeks.The clinical results showed that Nemluvio+topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), met all endpoints compared to the placebo group.The proportion of patients achieving at least 75% improvement in the Eczema Area and Severity Index (EASI-75) was 43.5% and 42.1% in the Nemluvio+TCS/TCI treatment groups in the ARCADIA 1 and 2 studies, respectively, compared to 29% and 30.2% in the placebo groups, demonstrating a statistically significant difference between the two groups.In particular, a statistically significant difference in pruritus compared to the placebo group was observed starting from 48 hours after administration, confirming Nemluvio's rapid itch-relief effect. At weeks 4 and 16, more than twice as many patients in the Nemluvio+TCS/TCI group experienced clinically meaningful itch relief (PP-NRS improvement of 4 points or more) compared to the placebo group.OLYMPIA 1 and 2 were conducted on 286 and 274 adult patients, respectively, aged 18 and older, with moderate-to-severe prurigo nodularis. In these trials, Nemluvio monotherapy met all endpoints compared to the placebo group.Nemluvio demonstrated a consistent safety profile across all clinical programs. The incidence of serious adverse events (SAE) was similar to that of the placebo group, and most adverse events were mild to moderate and manageable.Yang Won Lee, President of the Korean Atopic Dermatitis Association (Department of Dermatology, Konkuk University Hospital), explained, "Atopic dermatitis and prurigo nodularis are chronic inflammatory neuro-immune diseases where symptoms such as 'itching' cause chronic insomnia, fatigue, and various psychological stresses, seriously degrading the quality of life for patients."Lee added, "With the introduction of a new biologic targeting the IL-31 receptor, a key pathway for itching, to the domestic market, we hope to alleviate the suffering of patients with moderate-to-severe atopic dermatitis and prurigo nodularis and see another meaningful advancement in long-term disease management."CEO Jaihyuk Lee, stated, "Based on our long-standing expertise in the field of dermatology, Galderma has introduced a new biological treatment option that can meet the unmet medical needs of patients with atopic dermatitis and prurigo nodularis. We expect Nemluvio, the first to directly inhibit the interleukin-31 pathway, to provide patients with more effective and sustainable treatment opportunities and bring substantial changes to their daily lives."Galderma Korea plans to launch Nemluvio in the second half of this year. The company has completed the application for health insurance reimbursement listing to secure faster access to treatment for patients with atopic dermatitis and prurigo nodularis.
- Company
- Biologic for asthma, 'Nucala' autoinjector can be prescribed
- by Eo, Yun-Ho Jan 27, 2026 06:54am
- Product photo of Nucala Auto-InjectorThe injectable formulation of the antibody medicine Nucala is entering the prescription area of general hospitals.GSK's Nucala Auto-Injector (mepolizumab), a treatment for severe neutrophilic asthma, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center Seoul and Seoul National University Hospital, as well as medical institutes, including Kangdong Sacred Heart Hospital, Soon Chun Hyang University Hospital Cheonan, Jeonbuk National University Hospital, and Ajou University Hospital. Nucala Auto-Injector was approved in Korea in March of last year and was launched as a non-reimbursed drug in November of the same year after securing a distribution channel and quantity of stocks. Nucala Auto-Injector conditionally passed the Drug Benefit Evaluation Committee (DBEC) of the Health Insurance Review and Assessment Service (HIRA) on the 15th. Attention is focused on whether Nucala would succeed in obtaining reimbursement listing following the launch of the new formulation and the expansion of areas.Indications for the new autoinjector formulation have been added beyond the treatment of severe eosinophilic asthma in ▲existing adult and adolescent patients aged 12 and older to include eosinophilic granulomatosis with polyangiitis (EGPA) in adults and ▲hypereosinophilic syndrome (HES) in adults.Nucala is a self-administered injectable used to treat eosinophilic diseases. It is indicated as an add-on maintenance therapy for severe eosinophilic asthma (SEA) in patients aged 12 and older, for adult patients with EGPA, and for adult patients with HES, excluding those who are FIP1L1-PDGFRα-positive.The autoinjector formulation offers patients the convenience of self-administering the drug at home. This has been demonstrated through a self-administration success rate of over 96%, high patient preference, and ease of use.Meanwhile, Nucala is demonstrating increased competitiveness by securing an indication for chronic obstructive pulmonary disease (COPD). This medication received additional approval from the U.S. FDA this May as an 'add-on maintenance treatment for adult COPD patients with an eosinophilic phenotype.'The approval was granted based on the results of the Phase 3 MATINEE and METREX studies. In these studies, among a broad spectrum of COPD patient groups with an eosinophilic phenotype, the Nucala-administered group showed a significantly lower annual rate of moderate to severe exacerbations compared to the placebo group.
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- Janssen enters price negotiations for Opsynvi’s reimb in KOR
- by Eo, Yun-Ho Jan 27, 2026 06:54am
- Attention is growing over whether a newly reimbursed treatment option will emerge in the underserved field of pulmonary arterial hypertension (PAH).According to Dailypharm coverage, Janssen Korea accepted the ‘price below the assessed amount’ proposed by the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee last December and recently began price negotiations with the National Health Insurance Service for the pulmonary arterial hypertension (PAH) treatment ‘Opsynvi (macitentan/tadalafil).’The final approved indication for Opsynvi that passed DREC is “long-term treatment of adult patients with WHO Functional Class II–III pulmonary arterial hypertension.”Opsynvi, which received approval in the United States in March 2024 and in Korea in July last year, is a fixed-dose combination of the PDE5 inhibitor Cialis (tadalafil) and the endothelin receptor antagonist (ERA) Opsumit (macitentan). Its key advantage lies in improved dosing convenience.The efficacy of Opsynvi was demonstrated in the Phase III A DUE trial, which compared the efficacy and safety of the Opsynvi combination therapy with monotherapy using either Opsumit or Cialis.After 24 months of follow-up, Opsynvi showed up to a 29% greater reduction in pulmonary vascular resistance (PVR), the primary endpoint, compared with either Opsumit or Cialis monotherapy.As of 2023, the number of PAH patients in Korea is estimated at approximately 3,600, with the average patient profile being women in their 40s, who often play central roles in both society and family life. While the 5-year survival rate has significantly improved compared to the past, 3 out of 10 pulmonary arterial hypertension patients in Korea still die within 5 years.PAH is a rare, intractable, and progressive disease, in which delaying disease progression has a direct impact on patients’ quality of life and survival. To date, no curative pharmacologic treatment has been established, and existing therapies primarily aim to relax thickened pulmonary arteries to alleviate symptoms.Meanwhile, the emergence of new drugs is expected to transform the domestic PAH treatment landscape.In June 2025, Bayer’s Adempas (riociguat) was added to the reimbursement list nearly 10 years after its initial approval. Winrevair (sotatercept) by MSD Korea, selected for the ‘Approval-Evaluation-Negotiation Parallel Review Project, is currently undergoing reimbursement procedures.
