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- 2026-03-17 14:58:36
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- [Reporter’s View] MOHW-Industry clash over reform plan
- by Lee, Jeong-Hwan Mar 17, 2026 09:22am
- The biggest justification for the drug pricing reform plan, which the Ministry of Health and Welfare is accelerating, is “improving the structure of the domestic pharmaceutical industry with a focus on domestically developed new drugs.”Minister Eun Kyoung Jeong and Second Vice Minister Hyung-Hoon Lee have expressed their ambition to create a drug pricing environment that properly rewards pharmaceutical companies that generate innovative value through new drugs, as well as those that are willing to develop medicines essential for public health and life despite low profitability.The ministry has also emphasized the need for a swift overhaul of Korea’s pharmaceutical ecosystem, in which more than 100 companies obtain generic approvals for each active ingredient in a scattered and individual manner, resulting in excessive sales-promotion competition.The domestic pharmaceutical industry, however, is strongly opposing the reform plan, questioning its effectiveness. Companies that have built clinical achievements in new drugs and improved drugs and contributed to the development of Korean new drugs argue that the reform plan, which centers on price cuts for already listed generics and preferential pricing for innovative pharmaceutical companies, will, in fact, bring considerable regression to the domestic pharmaceutical industry.They point out that both the reform plan first unveiled by the Ministry on November 28 of last year and the revised version presented at the Health Insurance Policy Deliberation Committee’s subcommittee meeting on the 11th of this month are far removed from policies that genuinely benefit the “real pharmaceutical companies” that have demonstrated tangible achievements in advancing the domestic pharmaceutical industry and improving public health.A closer look at the domestic industry’s position shows that there is no disagreement with the broad policy direction of rewarding companies that have produced new drug R&D outcomes and contributed to manufacturing drugs vulnerable to supply instability, while cutting prices for those that have not, thereby encouraging new drug creation and a stable supply of essential medicines.The problem is that the Ministry of Health and Welfare’s reform plan cannot escape criticism that “the devil is in the details”—a cliché, but one that rings true.The main point of criticism from pharmaceutical companies regarding the Ministry’s reform plan is the “price cuts for already listed generics.”The Ministry has proposed a policy that uniformly cuts the prices of already listed generics without significant differentiation between pharmaceutical companies that have consistently maintained innovation and continued financial investment, and those that have relied on contract manufacturing of generics to generate profits.That is precisely the clause in the reform plan first disclosed on November 28 last year, which proposed lowering the current generic pricing ratio of 53.55% uniformly to the 40% range.Later, in the revised proposal presented at the HIPDC subcommittee on the 11th, the ministry adjusted the generic pricing ratio from the 40% range to the low-to-mid 40% range, while at the same time establishing a provision to temporarily defer price cuts for already listed generics for certified innovative pharmaceutical companies and companies deemed equivalent to innovative pharmaceutical firms.However, this was accompanied by a proviso stating that the deferment would not apply to ingredients with ‘21 or more listed products.’Pharmaceutical companies argue that the price reduction deferral for innovative pharmaceutical companies does not offer significant merit or benefit, and that, given the proviso regarding the 21-product threshold, the actual benefit effectively converges to zero.They argue that the price reduction deferral provision for innovative pharmaceutical companies appears, at first glance, to be a perfectly fine and sweet piece of fruit, but when you cut it open and look inside, it is rotten to the core—a regulation that has no real substance.Pharmaceutical companies also express dissatisfaction with the preferential drug pricing regulations designed by the Ministry of Health and Welfare, claiming that they are constrained by a piecemeal surcharge system and cannot generate any substantial price benefits, no matter how hard they try. The logic goes that if the government truly wants to build an innovative pharmaceutical ecosystem, it must go beyond mere drug price markups. Through inter-ministerial consultations, the government needs to dramatically strengthen tax benefits and create policies that allow pharmaceutical companies to see tangible benefits, such as regulatory exemptions for those contributing to the production of high-quality medicines, so that companies can generate profits that can then be reinvested into new drug R&D.Then why are the Ministry of Health and Welfare and the pharmaceutical industry clashing so sharply over the same reform plan when they share the same policy objective?Ultimately, it is due to insufficient public-private consultation between the government and the industry before the draft reform plan was disclosed on November 28, resulting in a drug pricing system that started strong but fizzled out.Despite growing backlash from the pharmaceutical industry immediately after the draft was released, the Ministry of Health and Welfare did not engage in any meaningful consultations with pharmaceutical companies until the revised proposal was prepared. The only face-to-face case between the ministry and the pharmaceutical industry was a single working-level consultation in which officials from around 20 pharmaceutical companies were gathered and asked to submit fragmented opinions.Multiple pricing managers at pharmaceutical companies say, “We have worked in market access and drug pricing policy for 10 or even over 15 years, but we have never seen the ministry put forward such a sweeping and unilateral drug pricing reform plan and then make so little effort at mutual consultation.”There is also strong criticism saying, “We don’t understand why the Ministry is turning a deaf ear and continuing with unilateral administration. If this continues, a pricing system will be established in which generic prices for domestic pharmaceutical companies are cut in order to fund innovative new drugs from global pharmaceutical companies. That would be the exact opposite of the ministry’s stated policy goal of fostering the domestic pharmaceutical industry and building a pharmaceutical environment based on new drugs.”There are even accusations that the ministry is merely kowtowing to the Trump administration’s pressure regarding reciprocal drug tariffs, having drafted a drug pricing reform plan out of fear of offending the US, and is now refusing to respond to any requests for revisions.The one thing the domestic pharmaceutical industry is asking of the ministry is a pause on the drug pricing reform plan that has been pushed forward hastily without mutual consultation.Pharmaceutical companies are calling on the ministry that, if it truly intends to design and operate the reform plan with the real goal of pharmaceutical industry innovation, it should stop insisting on a unilateral and coercive proposal and instead set a final timetable even now, promptly launch a public-private joint governance framework on the drug pricing reform plan, and derive a fully revised version.The unwavering stance of solid domestic pharmaceutical companies dedicated to innovation is that the reform plan and amendments presented by the Ministry of Health and Welfare to date are absolutely insufficient to create global blockbuster-level domestic new drugs, resolve crises involving essential medicines and medicines with unstable supply, solve the problem of generic drug proliferation, and eradicate rebate competition caused by pharmaceutical companies trapped in contract generic manufacturing, all of which are necessary to protect both a healthy domestic pharmaceutical environment and the public’s right to health.The words of one pricing manager that I heard while covering the reform continue to ring in my ears. “If the goal of this price cut is simply to reduce drug spending in the National Health Insurance budget, then there is nothing more to say. But we cannot agree at all with the ministry’s claim that its administrative rationale is preferential treatment for innovative pharmaceutical companies and building a new drug ecosystem. If the goal is to foster the pharmaceutical industry and reward real pharmaceutical companies, why are drug prices being cut across the board? Why does the ministry insist on turning a blind eye to the reality where only global big pharma companies end up laughing while domestic pharmaceutical companies are sweating bullets, calculating their losses? Rather than engaging in media stunts, wouldn’t it be the proper attitude for an administrator to put their heads together with industry practitioners and design a proper system?”
- Policy
- Boehringer discontinues original meloxicam 'Mobic Capsules' in KOR
- by Lee, Tak-Sun Mar 17, 2026 09:22am
- Product photo of 'Mobic Capsules''Mobic Capsules,' the original drug of the Non-Steroidal Anti-Inflammatory Drug (NSAID) meloxicam, is set to discontinue its supply in South Korea.Boehringer Ingelheim's headquarters has decided to stop imports, with product stocks expected to be depleted by April next year. The decision to withdraw from the Korean market is interpreted as a result of low sales performance and a market saturated with numerous alternatives of the same ingredient and class.According to industry sources on the 16th, Boehringer Ingelheim Korea has notified distributors regarding the discontinuation of Mobic Capsules.Boehringer Ingelheim stated, "The company has decided to discontinue the supply after recognizing that a wide variety of alternative treatments are already available in the Korean market." The company added, "Currently imported stocks will be supplied until they are exhausted, noting that the expected depletion date may vary depending on usage volume. The projected depletion for Mobic Capsules 7.5mg is around April next year, while Mobic Capsules 15mg is expected to run out by March next year."Mobic is an NSAID containing meloxicam as its active ingredient. It is effective in alleviating inflammation and pain associated with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis by selectively inhibiting COX-2. While it tends to have fewer gastrointestinal side effects compared to traditional anti-inflammatory drugs, it carries risks of blood clots and cardiovascular issues; therefore, it should be taken at the lowest effective dose for the shortest duration possible.Currently, there are 82 meloxicam products in South Korea at the 7.5mg dose and 15 at the 15mg dose. Even with the withdrawal of the original brand, the impact of the supply disruption is expected to be minimal due to the abundance of substitute medications.Mobic's sales have also been decreasing. According to UBIST, its outpatient prescription sales last year were KRW 1.5 billion, a 2% decrease from the previous year. This is a significant gap compared to Celebrex, another drug in the same NSAID class, which recorded KRW 41.7 billion in outpatient prescriptions last year.Consequently, Boehringer Ingelheim may have decided to halt supply to focus on other pharmaceutical products, given Mobic's low profitability in the Korean market.
- Policy
- Generics companies challenge ₩100B Lixiana·Livalozet mkt
- by Lee, Tak-Sun Mar 17, 2026 09:22am
- LixianaGeneric drug development is accelerating for Lixiana (edoxaban tosylate hydrate, Daiichi Sankyo Korea) and Livalozet (pitavastatin calcium + ezetimibe, JW Pharmaceutical), both of which are approaching the end of their exclusivity periods.Because both drugs have recorded more than KRW 100 billion in prescription sales, they are emerging as major targets for generic manufacturers this year and next.In the case of Lixiana, it has been disclosed that 13 products have applied for approval this year alone.According to the Ministry of Food and Drug Safety on the 16th, under the approval-patent linkage system, the original company was notified of marketing authorization applications filed for 13 generic products containing edoxaban tosylate hydrate in 2026.The recent increase in Lixiana generic approval applications is due to the fact that its substance patent is scheduled to expire on November 10 of this year.As for the pharmaceutical composition patent, which is scheduled to expire on August 21, 2028, most generic manufacturers have already succeeded in circumventing it through passive scope-of-rights confirmation trials. Once the patent expires, there will be no obstacles to launching generic drugs on the market.Lixiana is a direct oral anticoagulant (DOAC) whose prescription volume has continued to expand as it replaces warfarin. According to UBIST, its outpatient prescription sales alone reached KRW 117.5 billion last year.Generic companies had made attempts to invalidate the substance patent due to its strong commercial value, but failed. In addition to the original product, nine follow-on companies have already obtained product approvals, and their generic versions are expected to be launched after the substance patent expires.Since no follow-on product has secured first generic exclusivity, it appears that many products will flood the market simultaneously upon expiry of the substance patent, without restrictions on sales.LivalozetThere is also a strong possibility that a large number of generics will emerge for Livalozet, which posted KRW 117 billion in outpatient prescription sales last year. On the 13th, Nelson Korea, Pharmbio Korea, and Austin Pharmaceuticals all received approval on the same day for their bioequivalence study protocols for generic development.Generic development has already begun in earnest since 2024, with many pharmaceutical companies aiming to file applications. Applications can be submitted after the Livalozet re-examination period ends on July 27 next year.Livalozet is a dyslipidemia treatment combining pitavastatin and ezetimibe, and it has gained popularity due to its lower risk of diabetic side effects and strong lipid-lowering efficacy.In addition to the original company, JW Pharmaceutical, 5 companies have directly launched products with the same active ingredients through their own clinical trials. Ahn Gook Pharmaceutical, Boryung Pharmaceutical, Dongkwang Pharmaceutical, Hanlim Pharm, and Daewon Pharmaceutical launched related products in the second half of 2023 and have continued rapid growth. Last year, Ahn Gook Pharmaceutical’s Pevarozet recorded KRW 29.2 billion in outpatient prescription sales, while Daewon’s Tavalozet recorded KRW 18.2 billion. These companies also succeeded in launching their products early by invalidating Livalozet’s use patent.More recently, low-dose products combining pitavastatin 1 mg and ezetimibe 10 mg have also appeared. In January, Ilsung IS, Ildong, Daewoong, and Hanlim obtained approvals for related products, and this month, JW Pharmaceutical also received approval for a new product.Given recent sales trends, there is a high likelihood that generic drugs will flood the market once the re-evaluation period ends next July.
- Company
- Adjuvant immunotherapies shift gastric cancer trt paradigm
- by Son, Hyung Min Mar 17, 2026 09:22am
- Cancer immunotherapy 'Imfinzi'Major immune checkpoint inhibitors have demonstrated effects in pre- and post-operative adjuvant therapy. A paradigm shift in the treatment of gastric cancer is expected.According to industry sources on the 17th, the addition of an indication for the immunotherapy 'Imfinzi (durvalumab)' in advanced gastric cancer is imminent. AstraZeneca Korea anticipates approval within this month.While East Asia is notable for excellent early diagnosis and surgical outcomes, the risk of recurrence due to residual micrometastases remains high for patients with Stage 2–3 locally advanced disease. A perioperative treatment strategy, administering anticancer drugs both before and after surgery, has emerged as a solution to improve clinical outcomes.According to the final analysis of the Phase 3 MATTERHORN trial presented at the European Society for Medical Oncology (ESMO 2025) in Berlin last October, Imfinzi's perioperative adjuvant therapy significantly improved overall survival (OS) with statistical significance. Furthermore, clinical results for Asian patients, including South Koreans, were introduced at ESMO ASIA 2025.A total of 180 Asian patients participated in this analysis. The Asian cohort had a higher proportion of high-risk patients, with a greater frequency of T4 staging and lymph node positivity compared to the overall study population.Despite this, the Imfinzi combination therapy showed positive results, reducing the risk of disease progression by 26% in the event-free survival (EFS) endpoint compared with the placebo combination group. The 24-month EFS rate was 72.1% for the Imfinzi group, higher than the 64.2% in the placebo group. As the median EFS has not yet been reached in either group, the treatment benefit may become even more pronounced during long-term follow-up. The OS benefits were also consistent with the previous global clinical data.A particularly striking result was the pathological complete response (pCR). In the Asian cohort, the Imfinzi combination increased the proportion of patients whose tumors completely disappeared at the time of surgery to 18.9%, more than triple the 5.6% recorded in the placebo group. This level is similar to the overall analysis results, demonstrating that Imfinzi can significantly enhance tumor shrinkage effects during the preoperative phase.Safety was also confirmed to be at a manageable level, with no specific increase in toxicity compared to the standard FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) regimen. There was no significant difference in Grade 3 or higher adverse events between the two groups, and treatment discontinuation rates were similar, indicating no new safety concerns arising from the addition of Imfinzi. Given that FLOT itself is an intensive regimen, this is interpreted as an important finding.Based on these clinical results, the U.S. Food and Drug Administration (FDA) last month approved Imfinzi monotherapy as maintenance treatment following FLOT combination therapy in adult patients with resectable gastric and gastroesophageal junction adenocarcinoma.While surgery remains the cornerstone of curative treatment for gastric cancer, there is a growing global consensus, including in Asia, that surgery alone is often insufficient for a full cure. The MATTERHORN study has shown that administering immunotherapy in combination with FLOT before surgery, followed by radical resection and subsequent treatment, can meaningfully improve long-term outcomes.Clinical trials of major immunotherapies in perioperative adjuvant therapyCancer immunotherapy 'Keytruda'The attempt to integrate immunotherapy into perioperative care is not limited to Imfinzi. Various studies combining different immunotherapies with chemotherapy are confirming the potential for expanding gastric cancer treatment strategies.For example, improvements in preoperative pathological response rates have been reported in several studies, including studies involving avelumab + FLOT (MONEO), sintilimab + FLOT, toripalimab + SOX, and tislelizumab + SOX. Some studies are also exploring strategies that combine immunotherapy with anti-angiogenic agents or radiation therapy.Recently, the potential to improve tumor response rates has also been identified in preoperative adjuvant strategies involving the PD-1 inhibitor Tevimbra (tislelizumab), further raising the possibility of expanding preoperative immunotherapy.However, not all immunotherapies have achieved the same level of success.MSD's Keytruda (pembrolizumab) demonstrated improved pCR in the Phase 3 KEYNOTE-585 study evaluating a perioperative adjuvant strategy but failed to improve EFS, thus failing to meet its primary endpoints.
- Policy
- Approval of HER2-bispecific Ab 'zanidatamab' in KOR imminent
- by Lee, Tak-Sun Mar 16, 2026 09:25am
- BeOne Medicines' 'zanidatamab (product name: Ziihera 300mg),' a HER2-targeted bispecific antibody, is likely to be approved soon.Zanidatamab is the first HER2-targeted therapy for biliary tract cancer (BTC) approved by the U.S. FDA. Once it is introduced to the Korean market, this drug is expected to improve treatment outcomes for local patients significantly.According to industry sources on the 12th, the Ministry of Food and Drug Safety (MFDS) recently completed the safety and efficacy evaluation for zanidatamab. Once a "suitable" decision is made from this review, only the final administrative granting of the license remains. Furthermore, under the "Approval-Reimbursement Linkage System," the company can apply for insurance coverage through the Health Insurance Review and Assessment Service (HIRA) immediately following the completion of the safety/efficacy review.In November 2024, the U.S. FDA granted accelerated approval of zanidatamab for patients with previously treated HER2-positive advanced or metastatic BTC. There has been a high unmet medical need in HER2-positive BTC patients.Treatment options for HER2-positive BTC have been extremely limited. BTC is known for its poor prognosis, with a 5-year survival rate of less than 5% once metastasized. In the pivotal HERIZON-BTC-01 clinical trial, the zanidatamab group showed an objective response rate (ORR) of approximately 52%, and a median duration of response (DOR) of approximately 14.9 months.Following its FDA approval, launch in Korea was expedited after the drug was selected for the Global Innovative products Fast Track (GIFT) program in December 2024. In Korea, the specific indication was submitted for approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive (IHC 3+) biliary tract cancer.Unlike conventional monoclonal antibodies, zanidatamab is a bispecific antibody that binds simultaneously to two distinct sites on the HER2 (Human Epidermal Growth Factor Receptor 2) protein. This dual-binding mechanism allows for more potent inhibition of cancer cell growth.Beyond BTC, clinical development is currently expanding into gastric and gastroesophageal junction (GEJ) adenocarcinomas.BeOne Medicines underwent a global corporate rebranding last year. Beigene Korea was originally a China-based oncology developer; the company later changed its name to BeOne Medicines and moved its legal registration to Switzerland. In Korea, the company already supplies innovative oncology drugs, including Brukinsa (zanubrutinib) and Tevimbra (tislelizumab).Ziihera is a new drug originally developed by Jazz Pharmaceuticals. BeOne Medicines holds the commercialization rights for the Asia-Pacific region.
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