- LOGIN
- MemberShip
- 2026-04-04 03:20:01
- Policy
- Keytruda’s reimb for gastric cancer will be redeliberated
- by Lee, Tak-Sun Dec 20, 2024 05:46am
- The application to expand the gastric cancer indication for the immuno-oncology drug Keytruda (pembrolizumab, MSD) has been given a ‘redliberation’ decision. The drug is currently seeking reimbursement for 17 indications, but financial issues have prevented a conclusion. The Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee held its 9th meeting for 2024 on the 18th and deliberated on the proposed reimbursement standards for anticancer drugs. Keytruda’s result was the center of attention. MSD, the maker of Keytruda, has applied for reimbursement expansion for 17 indications. The CDDC had deliberated Keytruda’s agenda 4 times but deferred the decision due to the submission of an additional financial sharing plan. It was hoped that MSD would present its financial plan and reach a new conclusion, but the outcome was the same. The 9th CDDC meeting deliberated on 2 recent applications for gastric cancer indications for Keytruda but decided to redeliberate the case without reaching a conclusion. On the other hand, expanded reimbursement standards were successfully set for Zytiga (abiraterone acetate, Janssen) and Lorviqua (lorlatinib, Pfizer). The coinsurance rate for Zytiga was reduced from 30% to 5% as a treatment of asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer reduction from 30% to 5%, and reimbursement standards were set for Lorviqua as a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). On the new drug front, the lymphoma drug Jaypirca (pirtobrutinib, Lilly) achieved reimbursement coverage. Roche's Columvi (glofitamab) and AbbVie's Epkinly (epcoritamab) failed to set reimbursement standards.
- Company
- LG Chem wins Zemiglo patent dispute
- by Kim, Jin-Gu Dec 20, 2024 05:46am
- Pic of Zemiglo LG Chem has won the 2nd trial of a patent dispute over the use of DPP-4 inhibitor diabetes drug Zemiglo (gemigliptin). The company was able to reverse its first trial loss and won the second trial, enabling it to prevent patent challengers from launching their generic versions early. The pharmaceutical industry's attention has now turned to another second trial. LG Chem is battling generic companies in patent court over the invalidity of its use patent. If LG Chem wins, it will make it even harder for generics to launch their generic versions of Zemiglo early. The 5th Division of the Patent Court ruled in favor of the plaintiffs in the passive scope of rights confirmation review trial filed by LG Chem against 8 generic companies, including Shin Poong Pharm. The court overturned the decision of the Patent Trial and Appeal Board and ruled in favor of the original company, LG Chem. The Zemiglo patent dispute began in May last year when generic companies filed for both passive confirmations of scope and patent invalidation at the same time. Shin Poong Pharm, Daehwa Pharmaceuticals, DongKoo Bio&Pharma, Boryung, Sam Chun Dang Pharm, Celltrion Pharm, Jeil Pharmaceutical, and Korea Prime Pharm were among the companies that filed for the judgment. Generic companies have filed two judgment requests for the same patent, signaling their intention to launch generics early. They planned to avoid or invalidate the use patent and launch generics early. In the first instance, the generic companies won. In April this year, they won the patent avoidance case, and in September, they won the invalidation case. LG Chem appealed the decision to the patent court. Upon appeal, LG Chem got the first laugh. The patent court overturned the first court's ruling that was in favor of generics and sided with LG Chem. The pharmaceutical industry's attention now turned to the company’s appeal of the invalidity judgment, which is yet to be decided. Upon. If LG Chem wins, it will likely block generic entry until 2039, when the patent expires. However, this also depends on the generic companies’ appeal to the Supreme Court and a reversal. On the other hand, if LG Chem loses, it will encourage generic companies to launch their product early. If the generic companies win and Zemiglo’s patent is invalidated, they can overcome the remaining two patents and launch Zemiglo-Zemimet generics. Quarterly prescriptions of Zemiglo and Zemimet (Unit: KRW 100million, Data: UBIST) Zemiglo is currently protected by three patents. The use patent expires in October 2039, the salt-hydrate patent expires in October 2031, and the substance patent expires in January 2030. For Zemimet (gemigliptin + metformin), there are two additional composition patents that expire in October 2033 and May 2039, respectively. Generic companies plan to overcome Zemiglo’s use patent first and then overcome the remaining patents to launch generics early in time for the expiration of its composition patent. According to the market research institution UBIST, Zemiglo-Zemimet is the top prescribed diabetes drug in the DPP-4 inhibitor class. In the third quarter of this year, Zemiglo's prescriptions totaled to KRW 10.5 billion and Zemimet's totaled to KRW 25.6 billion, up 1% year-on-year. Zemiglo and Zemimet became the leading diabetes drugs in the third quarter of last year.
- Policy
- Basic refund type-drugs granted early RSA termination
- by Lee, Tak-Sun Dec 20, 2024 05:46am
- Only drugs categorized as a basic refund type are possible when a pharmaceutical company wishes to terminate the Risk Sharing Agreement (RSA) early. However, pharmaceuticals on the cost-effectiveness evaluation waiver track, demonstrating cost-effectiveness, can be submitted for negotiation through the renewal of the agreement. The National Health Insurance Service (NHIS) has finalized the 'Guidelines for Drug Price Negotiations and Detailed matters.' On the afternoon of December 19, the NHIS held a briefing session at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA) to explain the revisions made to the 'Guidelines for Drug Price Negotiations' and the 'Guidelines for Drug Price Negotiations and Detailed matters.' The finalized revised guidelines include the changes reported to the Health Insurance Policy Review Committee meeting held in December 2024. These changes are part of the 'Proposal to reflect the new drug's innovative value and the nation's healthcare security.' Health Insurance Review and Assessment Service (HIRA) included these updates in the 'Specific evaluation criteria of new drugs and medicines in consideration for negotiation' during revisions made in August and December. Meanwhile, the Ministry of Health and Welfare (MOHW) incorporated these changes in the October administrative notice outlining partial revision to the drug reimbursement and adjustments criteria. The NHIS has improved its policies to align with regulatory revisions. The revised guidelines for drug price negotiations and detailed matters for RSA underwent consultation starting on November 28 and concluded on December 4. On the afternoon of December 19, the NHIS held a briefing session at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA) to explain the revisions made to the Despite differing opinions from some associations, the revisions were finalized as initially proposed. One association suggested that early termination should be allowed for all RSA types. However, the final decision limited early termination to basic refund RSA type only. Current policy states that companies can request early termination of an RSA, but under the revised guidelines, this will be limited to basic refund RSAs. However, for cost-effectiveness-evaluated drugs that have demonstrated cost-effectiveness through the HIRA’s Drug Reimbursement Evaluation Committee (DREC) review, companies, and NHIS can renegotiate to adjust reimbursement ceilings, reset expected claim amounts, or modify·terminate total expenditure-capped RSAs. This opens the possibility of terminating total expenditure-capped RSAs through renewal of agreement. Additionally, one association suggested simplifying re-renewal processes for all RSA types but was rejected. The revision will apply only to basic refund RSAs, as this approach aligns with existing HIRA regulations, which NHIS incorporated into its guidelines. The negotiation period for RSA renewals following contract expiration will also be reduced. If renewal or termination negotiations fail, the NHIS and the company can renegotiate once under the Minister of Health and Welfare’s directive. The drug is removed from the reimbursement list if this second negotiation fails. However, based on the revised guidelines, in case of a negotiation failure, the NHIS and the company will have 60 days for renegotiation under the directive of the Minister of Health and Welfare without any extensions. If renegotiation fails, the drug will be removed from the reimbursement list. "Currently, negotiations can take up to 300 days, which burdens the individuals involved," Oh Se-rim, head of the HIRA's Pharmaceutical Benefits Department, stated. "The revised guidelines reduce this period to a maximum of 240 days." The updated proposal indicates that when applying for reimbursement listings of the same formulation under a RSA, the NHIS and associated organizations may mandate the applicant to sign a confidentiality agreement and provide details regarding the RSA associated with the drug. The recent revision of pricing negotiation guidelines remains intact. Updates include a 30-day timeframe for essential medicines. Additionally, a new provision permits 'pre-negotiations' to occur during the evaluation period conducted by the HIRA. The NHIS has already implemented this strategy in negotiations concerning drugs experiencing shortages, such as acetaminophen, after the COVID-19 endemic.
- Policy
- Cinacalcet impurities spread…Huons recalls product
- by Lee, Hye-Kyung Dec 19, 2024 05:53am
- The detection of excess 'N-nitroso cinacalcet' impurity has led to the recall of the kidney drug cinacalcet hydrochloride. The Ministry of Food and Drug Safety announced on the 17th that Huons’ Calcepara Tab 25 mg (cinacalcet hydrochloride) with 3 manufacturing numbers TTB201 (2025-08-16), TTB301 (2026-05-18), and TTB302 (2026-05-21) will be recalled by the manufacturer. The cinacalcet hydrochloride-based formulations are used for the treatment of secondary hyperparathyroidism in patients with chronic kidney failure undergoing dialysis, and the original drug product, Regpara Tab (cinacalcet hydrochloride), was first recalled on November 20th. List of approved cinacalcet drugs In early October, an Indian drug manufacturer decided to recall the drug due to the detection of nitrosamine impurities in the cinacalcet ingredient, raising the possibility of a recall in Korea. In early November, the U.S. Food and Drug Administration (FDA) announced a voluntary recall on its website after nitrosamines were found to exceed the FDA's recommended daily allowable intake limit. In Korea, Kyowa Kirin Korea recalled some lot numbers of two products, Regpara Tab 25mg and 75mg, due to excessive impurities detected in stability tests. The source of the N-nitroso cinacalcet is believed to be the reaction between the raw materials and excipients. Regpara Tab was launched in Korea in 2011 and became popular as soon as it was launched because it induces a decrease in parathyroid hormone (PTH) while reducing serum phosphorus (P), serum calcium (Ca), and Calcium-phosphorus product (CaxP) levels and it is easy to take once a day without the side effects caused by vitamin D preparations. In particular, generics have been entering the market at a rapid pace since the patent expired in 2017, and there are currently 11 generics approved for cinacalcet in Korea. According to the import and manufacturing performance of drugs disclosed by the Ministry of Food and Drug Safety, 2 doses of the original, Regpara, posted sales of KRW 5.8 billion at the current exchange rate. Alvogen Korea's ‘Cinacet Tab,’ Daewon Pharmaceutical's Repatzin Tab,’ and Yuyu Pharmaceutical's ‘Beneph Tab’ have posted figures of more than KRW 1 billion, while Calcepara Tab, which has been recalled, has posted nearly KWR 143.1 million. An MFDS official said, “Since impurities were detected in ingredients, excipients, and other components, we asked generic drug manufacturers to test whether excess N-nitroso cinacalcet were detected. We plan to consider necessary measures based on the results.” In response to the manufacturer's request for temporary ease of the tolerance standard and the opinions of medical expert organizations on its medical necessity, the MFDS will reportedly take measures such as temporarily raising the impurity threshold. However, manufacturers will be required to notify the agency within a month and implement a countermeasure plan for reducing impurities within 3 years. Meanwhile, Huons is conducting research to ensure that products exceeding the impurity standard are not distributed. It is considering various measures such as shortening the use period and removing or reducing impurities. “We are conducting various studies to reduce the risk of impurities, such as reduction measures,” said a Huons representative, ”and we will complete the research and development faster than the specified period so as not to disrupt the supply for patients.”
- Policy
- Sanofi signs PVA negotiations for hemophilia drug 'Alprolix'
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- Product photo of Alprolix The ceiling price for Sanofi's 'Alprolix,' a new treatment for hemophilia B, is expected to decrease through price-volume agreement (PVA) negotiations. This drug was approved in May 2017, and reimbursement listed in June of the following year. According to industry sources on December 18, the National Health Insurance Service (NHIS) and Sanofi-Aventis Korea agreed on Alprolix's PVA negotiations (TYPE-NA). Alprolix has been considered for the PVA negotiation for the first time after it was reimbursement listed in June 2018. The TYPE-NA negotiation is conducted when the ceiling price is adjusted by the TYPE-GA price or when the bill amount of the same product has increased by more than 60% or 10% from the previous year's bill, and the increase is more than KRW 5 billion. The current negotiation was possible because Alprolix's ceiling price had not been adjusted due to TYPE-GA negotiation, and it met the criteria for TYPE-NA negotiation four years after the first listing. This biological drug received approval in May 2017 as a daily preventive therapy to suppress and prevent bleeding, manage pre- and post-operative care, and reduce the frequency of bleeding in hemophilia B. The pharmaceutical company accepted price 100% below the weighted average price of substitute medicines and was exempted from undergoing the drug negotiation process. It only negotiated for the expected claim amount and successfully listed for reimbursement in June 2018. The ceiling price is KRW 1,181. Meanwhile, the Swedish biotechnology group Sobi owns Alprolix's global sales rights. Sobi partners with Sanofi to sell Alprolix. Sobi established a joint venture with Handok in South Korea in April, named 'Sobi-Handok.'
- Policy
- Hyperphosphatemia treatments undergo generation change
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- Drugs that improve hyperphosphatemia in patients with chronic kidney disease are undergoing a generation change in the domestic market. Following the launch of the new drug Nephoxil Cap (ferric citrate, Kyowa Kirin Korea) last year, generic drugs containing sevelamer have continued to grow, and news of the withdrawal of existing drugs is also arising. According to industry sources on the 18th, Fosrenol Tab (lanthanum carbonate), which was supplied by JW Pharmaceuticals in Korea, will be discontinued. Fosrenol has been imported and sold by JW Pharmaceuticals from Takeda. With the termination of the supply contract, its supply to the domestic market is expected to be gradually discontinued by February next year. Fosrenol is a non-calcium phosphate binding agent that was approved in Korea in January 2006. It formed a three-way tie with Renvela (Sanofi) and Invela (SK Chemical) as a treatment for hyperphosphatemia in 2022. However, Fosrenol’s competitiveness weakened as generic drugs containing sevelamer carbonate, such as Renvela and Invela, were released to the market in July 2022, and the new drug Nephoxil Cap was launched last year. Last year, sales of Renvela, Invela, and Fosrenol all declined. Renvela’s sales fell to KRW 9.2 billion in 2023, down 4% from the previous year, and Invela’s sales fell to KRW 7.4, down 15%. Fosrenol's sales were flat at KRW 4.1 billion ($4.1 billion), the same as the previous year. The emergence of sevelamer generics and new drugs are disrupting the existing market structure. Nephoxil, which was launched last year, is a drug for hyperphosphatemia in chronic kidney disease patients undergoing hemodialysis and is particularly praised for lowering the risk of side effects such as hypercalcemia and vascular calcification of calcium-based binders with iron-based binders. In particular, Kyowa Kirin Korea, which supplies the drug, not only succeeded in getting the drug on the reimbursement list within a year by accepting the weighted average price of KRW 377, which is 90% of the weighted average price of alternative drugs, showing competitivity in drug price. Not only new drugs but also the highest-selling sevelamer drug has seen its number of tablets increase to 9 due to the emergence of generics. This situation explains why Fosrenol, which showed stagnant sales, eventually withdrew from the domestic market. On the 5th, 3 Fosrenol products also withdrew their domestic marketing authorizations. “The market for hyperphosphatemia treatments has recently seen intensified competition as non-calcium-based drugs with fewer side effects have gained prominence due to expanded reimbursement,” said a pharmaceutical industry insider. ”In addition, the introduction of new drugs has weakened the competitiveness of existing products.”
- Company
- 'Vyloy' to expand treatment options for gastric cancer
- by Whang, byung-woo Dec 19, 2024 05:52am
- Vyloy (active ingredient: zolbetuximab), a Claudin-18.2-targeting gastric cancer therapy, is rising as the new treatment option for stage 4 gastric cancer despite an issue related to companion diagnostics. As the number of newly diagnosed patients with Claudin-18.2 increases in clinical practices, the drug will be more widely used from the early next year when it launches as non-reimbursed. Vyloy logoVyloy is the first and only Claudin-18.2-targeted treatment. A monoclonal antibody that is designed to work by binding to It binds to Claudin-18.2, a protein expressed in the stomach. In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with CLDN18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' It is gathering attention from experts since a new targeted treatment option for stage 4 gastric cancer has emerged decades after the introduction of 'trastuzumab'-based therapy for HER2-positive patients. At the Korean Society of Medical Oncology-American Association for Cancer (AACR) joint symposium held last month, two accounts of Phase 3 clinical trials were presented. The SPOTLIGHT and GLOW studies, which conducted sub-group analysis of Korean patients, show that the drug has reduced the risk of death by half in patients with locally advanced and metastatic gastric cancer. The Vyloy group had a median progression-free survival (PFS) of 12.8 months compared to 8.1 months of the placebo group, which shows that both groups had longer PFS than all patient groups. 12‧24 months PFS for the Vyloy group were 53% and 30%, and those for the placebo group were 32% and 23%. Additionally, the Vyloy group had a median overall survival of 30.0 months, twice longer than the 15.8 months of the placebo group. 12‧24 months overall survival for the Vyloy group was 78% and 54%, whereas those for the placebo group were 65% and 34%, demonstrating that the Vyloy group's death risk was lower by 50%. "The introduction of Vyloy, targeting the new biomarker for gastric cancer Claudin-18.2, will bring paradigm shift of the treatment outcome of locally advanced or metastatic gastric cancer with limited treatment options until now in South Korea," Dr. Keun-Wook Lee, Professor in the Department of Oncology at Seoul National University Bundang Hospital. The drug's clinical application in South Korea was likely to be delayed as a companion diagnostic (CDx) used to diagnose Claudin-18.2 has been considered for assessment as a new health technology. However, the drug is categorized as having 'companion diagnostic pricing (Level 1).' "The pathology department states that Level2 companion diagnostic pricing is needed for the drug that requires companion diagnostic. However, now, patients can be readily treated with the drug as Level1," Professor A from a tertiary general hospital, who requested to remain anonymous, said. In other words, If Vyloy's companion diagnostics had been assessed as a new health technology, the drug's entry into the domestic market would have been delayed by over one year. However, such concerns have now been resolved. Clinical anticipates Vyloy's prescription to be made in early 2025 when Vyloy launches in South Korea. "Diagnosis reveals that Claudin-18.2 is more frequent than expected with 3-4 individuals out of 10 new patients," Professor A said. "We expect the drug to be in stock by the end of January or February. Its use in patient treatment is expected to be higher."
- Policy
- Prior notification of drug permit changes extended to 2025
- by Lee, Hye-Kyung Dec 19, 2024 05:52am
- The operation of the pilot program, 'Advance Notification System for Drug Change Permit', which allows drug manufacturers and importers to apply for change permits on their preferred date, will be extended. According to industry sources on the 18th, the Ministry of Food and Drug Safety (MFDS) will extend the pilot project until December 31 next year to collect sufficient data to evaluate the system and in consideration of industry demand. The Advance Notification System for Drug Change Permit is a system in which the MFDS and drug manufacturer/importer discuss the date of a drug’s permit change in advance, taking into account the manufacturing and import schedule of the company before processing the change, and then approving the change according to the applicant's desired date. The system had been operated only for new drugs, orphan drugs, and advanced biopharmaceuticals until now. Still, as of May 30, the system had been expanded to include drugs subject to production, import, and supply interruption reports. In the case of drugs subject to production, import, and supply interruption reports, their inclusion in the system may be subject to change according to the list announced by the Health Insurance Review and Assessment Service in late December. Drug manufacturers and importers must obtain a change permit from the head of the MFDS when changes are made to authorized drugs, and then manufacture and import products reflecting the changes. Previously, when the MFDS’s approval process for a drug permit change application was completed, its approval was processed without any notification, making it difficult for companies to predict the date of approval. To address this, the MFDS has established an advance notification system for drug permit changes and plans to institutionalize it through evaluation after completion of the pilot program. The system allows a company that applies for a change permit and enter a notice of the desired change period into the NEdrug system after the MFDS completes review. The change date must be set after the statutory deadline, and extensions can be requested within the statutory period of the civil complaint. Adjustment of the date of change approval through the advance notification system is only applicable to cases where it is necessary to process (extend) the period later than the original processing period due to the manufacturing and import schedule of the drug in question in order not to affect the existing approval process.
- Company
- Kuhnil signs licensing agreement with Mochida
- by Whang, byung-woo Dec 18, 2024 05:55am
- Kuhnil Pharm announced on the 16th that it has signed a sales partnership agreement for Epadel, an original version of the highly purified eicosapentaenoic acid (EPA) ethyl ester formulation, with Mochida Pharmaceutical in Japan. Founded in 1913, Mochida Pharmaceuticals is a leading Japanese innovative pharmaceutical company that has played a leading role in the development of high-purity omega-3 fatty acid products. Epadel (generic name: icosapent) is a highly purified EPA ethyl ester formulation developed by Mochida as the world's first medical drug. The drug is indicated for hyperlipidemia and ulcer, pain, and chilliness associated with arteriosclerosis obliterans in Japan. Through this agreement, Kuhnil Pharm will own exclusive development and marketing rights to Epadel in Korea. Epadel has demonstrated an effect in preventing cardiovascular disease through Japan’s EPA Lipid Intervention Study (JELIS Study). Currently, Epadel’s active pharmaceutical ingredient is supplied by Nissui Corporation, which has advanced EPA purification technology and the capacity for mass production. Han-Kuk Lee, CEO of Kuhnil Pharm said, “The agreement allows us to add a new formulation to our existing portfolio, which includes Omacor and Rosumega, which have been leading the market for hyperlipidemia treatment, and further strengthen our leadership in the Korean hyperlipidemia market. Epadel will be a great treatment option for hyperlipidemia patients in Korea.
- Opinion
- [Reporter’s View] ERP hits industry again
- by Eo, Yun-Ho Dec 18, 2024 05:55am
- Another round of layoffs at multinational pharmaceutical companies are underway with the nearing end of the year. Starting in the second half of the year, 5 companies have already launched early retirement programs (ERPs). The reasons are varied. Whether it's their cash cow crisis, divestitures, or mergers and acquisitions, multinational pharmaceutical companies are taking a hard look at their situation and making layoffs where they deem necessary. This has become a common occurrence in the pharmaceutical industry. In fact, multinational pharmaceutical companies have made mergers and acquisitions (M&A) this year in a variety of rare disease areas, including autoimmune diseases, radiopharmaceuticals, cell therapies, and Alzheimer's disease treatments. They have focused on acquiring rare disease pipelines through small deals under $5 billion. Most of the spin-offs and divestitures of multinational pharmaceutical companies are driven by their “separation of innovation and legacy.” While the companies have undergone activities under the major premise of “choice and focus,” the spin-offs and divestitures have also brought a negative side effect - layoffs. Especially when it comes to layoffs as a result of divestitures, it's not your typical ERP. It's called voluntary retirement, but it's much less “resource-oriented." That's why the news of such an ERP process often leads to labor-management conflicts. The good news is that ERPs in multinational companies offer significant compensation. Especially ERPs that were initiated by spinoffs or selloffs often offer industry-leading compensation packages. For those who have been thinking about changing jobs, ERP can be a good thing. But not everyone wishes to change jobs. For some people, a company is more than just a place to make a living, it's a source of value and pride. When layoffs are unavoidable, companies should focus on maximizing compensation and succession. The coercion behind the word “voluntary” is something that needs to be addressed, and the size of the layoffs should not be vague. There are no good layoffs. Even if some people are happy, they are few and far between. Some people will feel a sense of loss and disconnection just knowing that they've been labeled as redundancies. As the company the employees relied on and were proud of, as an independent pharmaceutical company and not just a Korean subsidiary of a multinational pharmaceutical company, the companies should take the initiative to convince the headquarters if there is room for improvement and take an interest in the future of their employees.
