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- 2026-05-06 10:21:36
- Policy
- Celltrion rebrands and sells self-manufactured drugs
- by Lee, Hye-Kyung Jan 19, 2024 05:44am
- Celltrion Pharm will discontinue importing the original diabetes and hypertension drugs that it has successfully self-manufactured after acquiring all the rights, including sales rights and patents, from Takeda Pharmaceutical. According to the list of supply discontinuation drugs reported to the Ministry of Food and Drug Safety, the soon-to-be-discontinued drugs include Celltrion's diabetes drug ‘Nesina Tab (alogliptin benzoate),’ 12. 5mg and 25mg; ’ as well as ‘Nesina Act Tab (pioglitazone hydrochloride-alogliptin benzoate)’ 25/30mg, 25/15mg; and the hypertension drug ‘Edarbi Tab (azilsartan medoxomil potassium)’ 40mg, 80mg; and Edarbyclor (chlorthalidone-azilsartan medoxomil potassium) 40/25mg. Also, the company will discontinue sales of ‘ActosRyl Tab (glimepiride- pioglitazone hydrochloride)’ 30/4mg and 30/2mg due to deteriorating product profitability from decreased sales volume. In December 2020, Celltrion acquired all rights, including sales and patents, of Takeda Pharmaceutical's 12 ETC drug brands including ‘Edarbi’ and 'Nesina,' as well as 6 OTC drugs such as ‘Whituben Q’ and ‘Albothyl’ in 9 Asia-Pacific countries for USD 278.3 million (approximately KRW 30.74 billion), and has been preparing to self-produce and sell these products to ensure stable product distribution. The diabetes drug Nesina that is being discontinued was rebranded to ‘Celltrion Alogliptin Met’ and Nesina Act to ‘Celltrion Alogliptin Benzoate.’ In addition, the hypertension treatments Edarbi Tab and Edarbyclo Tab were approved as 'Celltrion Azilsartan Medoxomi Tabl' and 'Celltrion Azilsartanclo Tab,’ and have been localized. Celltrion Pharmaceutical said, "We have discontinued imports due to self-production. We will supply our own products to the market before the stock of imported products is exhausted, and we will establish a manufacturing plan according to market needs." In the case of its diabetes drug ActosRyl, the company said that it would terminate its sales due to the decline in sales volume with prescriptions of around 100,000 tablets per year, and because there are many existing single-agent drugs that contain glimepiride and pioglitazone. Meanwhile, the Celltrion Group announced in January that it will separately sell the sales rights to ETCs in all of the Asia-Pacific region excluding Korea, and OTCs in the Asia-Pacific region, that it had acquired from Takeda Pharmaceutical in 2020. The business rights for the ETC in the Asia-Pacific region is about KRW 209.9 billion, and Celltrion Group is expected to make a significant return on the KRW 138 billion investment it had made at the time of acquisition. However, the items that reported discontinuation of original imports due to in-house conversion and self-manufacture were excluded from the sale and will continue to be sold in Korea by Celltrion Pharm. Celltrion Group excluded the Asia-Pacific rights for Nesina, Actos, and Edalbi from the list of products it will sell.
- Company
- Hemlibra reduces risk of exercise-associated bleeding
- by Lee, Seok-Jun Jan 19, 2024 05:44am
- JW Pharmaceutical’s hemophilia A treatment ‘Hemlibra (emicizumab)’ The research findings, which include data on the physical activities of patients treated with JW Pharmaceutical’s hemophilia A treatment ‘Hemlibra (emicizumab)’ and their safety profile, have been published in the International Journal of Hematology (Int J Hematol). Hemlibra is an innovative new drug that mimics the function of blood coagulation factor VIII, which is usually deficient in patients with hemophilia. It is unique in that it can be used to treat hemophilia A in both patients with antibodies and those who are resistant to existing treatments (factor VIII drugs). A single subcutaneous injection of Hemlibra can yield a lasting preventive effect for up to four weeks. Last May, reimbursement subjects were expanded to patients with non-antibody severe hemophilia A patients aged one or older. According to the company, the research team led by Professor Keiji Nogami from the Department of Pediatrics at Nara Medical University conducted the study, which enrolled 107 patients with non-antibody severe hemophilia A with an average age of 35, from Jan. 2019 to May 2021. The research team evaluated the relationship between patients' physical activity and measurements such as bleeding events and safety using the electronic patient reporting application 'ePRO' and wearable activity trackers following Hemlibra treatments. The research findings showed that, following Hemlibra treatments, 47 out of 74 patients aged six or older engaged in various physical activities over eight days at 5 weeks, 25 weeks, 49 weeks, 73 weeks, and 97 weeks. ePRO recorded 396 physical activities, while wearable activity trackers recorded 329 activities. Based on the data from wearable activity trackers, walking exercise was the most common physical activity among patients, with 24 individuals (32.4%) participating. This was followed by cycling with 11 patients (14.9%) and soccer with 4 patients (5.4%). The range of activities patients engaged in included high-intensity exercises such as basketball, skiing, and tennis, in addition to soccer. In the ePRO data, it was observed that bleeding occurred only twice during the recorded exercise sessions. 106 patients with Hemophilia A reported a mean annualized bleeding rates (ABR) of 0.91. During the study, zero bleeds were reported in 57 patients, making 53.8% of the total. “This research holds significant value as it demonstrates that patients, when treated with Hemlibra, can participate in various physical activities without requiring additional injections of factor VIII drugs before exercise. We hope that Hemlibra will allow more individuals with Hemophilia A to engage in a wide range of physical activities without limitations, “ a representative from JW Pharmaceutical stated.
- Opinion
- [Reporter’s View] Forxiga withdrawal raises concern
- by Son, Hyung-Min Jan 19, 2024 05:44am
- AstraZeneca, the UK-based global pharmaceutical company, is withdrawing its diabetes treatment Forxiga (ingredient: dapagliflozin) from the Korean market, ten years since its approval in 2013 in Korea. Initially approved as SGLT-2 inhibitor-class diabetes treatment, Forxiga achieved success as its indications were expanded to include conditions like heart failure and kidney disease. Forxiga generated sales of 55 billion won in the previous year. However, AstraZeneca has decided to withdraw Forxiga from the Korean market, giving up annual sales of 50 million won. This decision entails not only the supply halt, but also the withdrawal of approval and reimbursement. What factors have influenced AstraZeneca to make such a decision? The prevailing analysis suggests that reduction in drug pricing was a significant factor in Forxiga’s withdrawal. The primary reason for the withdrawal of Forxiga is widely attributed to the price reduction resulting from the expiration of its patent. AstraZeneca Korea contested the government’s price reduction measure and initiated administrative litigation against them. Having granted suspension of the measure, Forxiga’s current drug price will be maintained through February. However, there is no guarantee that the price of Forxiga will remain at its current level after February. Forxiga’s price could be adjusted to 53.55% of its current price, which is around 730 won, due to patent expiration. Additionally, further reductions in the drug price may be possible due to expanded reimbursement criteria and the price-volume agreement program (PVAP). The drug price of Forxiga in Korea is currently less than 1/30th of the price in the United States. Further price reductions could potentially lead to complications in manufacturing. Furthermore, the cost for conducting clinical trials to expand its indications to include heart failure and kidney disease is substantial. Another factor that may have influenced Forxiga’s withdrawal is that price reductions in Korea can affect drug pricing in neighboring countries. East Asian countries, including China, Japan, Taiwan, and others, may demand drug price reductions referencing the price in Korea. As a global pharmaceutical company, the company needs to consider the potential impact on drug prices beyond Korea. Furthermore, factors such as commission expenses from joint marketing agreements and heightened competition resulting from generic releases may have influenced this decision. The concern is that the current withdrawal of Forxiga could be the beginning of the phenomenon known as ‘Korea Passing’ by global pharmaceutical companies. Entering the Korean market can be challenging for global pharmaceutical companies seeking to establish a presence in East Asia. The reductions in drug pricing and insurance reimbursement policies applied to innovative drugs make the Korean market less attractive to global headquarters. While it's understandable that the government seeks to implement fiscal measures to improve savings in a single national healthcare system like Korea's, global pharmaceutical companies cannot create a 'special drug pricing' exclusively for Korea. Furthermore, Korea employs various methods to reduce drug prices, including reevaluations of reimbursement adequacy, clinical reevaluations, price-volume agreements, and overseas price comparisons. Technology advancement is expected to result in the continuous development of innovative new drugs. Survival rates for diseases that were once life-threatening have improved for patients, and there is hope for recovery in the case of rare and incurable diseases. If these innovative new drugs cannot enter the domestic market in the future, Korean patients may have to seek medical treatment abroad. For patients to access innovative new drugs, there needs to be more communication between the government and pharmaceutical companies. It should not be a unilateral announcement, but an open approach aimed at improving patients’ access to innovative new drugs.
- Company
- Keytruda's reimb for 6 indications will be reviewed
- by Eo, Yun-Ho Jan 19, 2024 05:44am
- The reimbursement challenge for Keytruda continues this year. Although no results have been made, the company seems to be on a steady course in applying for reimbursement. According to industry sources, 6 indications of MSD Korea’s PD-1 inhibitor immuno-oncology drug Keytruda (pembrolizumab) are expected to be submitted to the Health Insurance Review and Assessment Service's Cancer Disease Review Committee for reimbursement deliberations at the committee’s first meeting this year. Keytruda, which attracted attention in June last year for submitting an application for coverage expansion for 13 indications, has so far received a re-deliberation decision for 7 of the indications - triple-negative breast cancer (TNBC), head and neck cancer, cervical cancer, bladder cancer, esophageal cancer, endometrial cancer, and colorectal cancer. The other 6 remaining indications are expected to be presented for deliberation this time. Specifically, the indications are: ▲ early triple-negative breast cancer; ▲adjuvant therapy after surgery for renal cell carcinoma; ▲advanced endometrial carcinoma; ▲MSI-H or dMMR metastatic small bowel cancer; ▲MSI-H or dMMR metastatic ovarian cancer; and ▲MSI-H or dMMR metastatic pancreatic cancer. As a Risk Sharing Agreement (RSA) drug, each indication must go through an evaluation procedure equivalent to that of a new drug in order to receive reimbursement extensions. Indications approved through Phase III trials must undergo pharmacoeconomic evaluation to prove cost-effectiveness, and indications approved based on Phase II trials must also undergo negotiations to apply for pharmacoeconomic evaluation exemptions. Therefore, whether the discussion on expanding Keytruda's reimbursement to a record number of indications, will produce results at the first CDDC meeting of 2024, remains to be seen. Meanwhile, Keytruda added a new first-line indication for gastric cancer at the end of last year, making it the first new first-line option for gastric cancer approved in 13 years, following ‘Herceptin (trastuzumab)’, which was approved in 2010. The approved gastric cancer indication is Keytruda's 26th indication.
- Company
- AstraZeneca begins ERP and business unit restructuring
- by Son, Hyung-Min Jan 18, 2024 04:51pm
- AstraZeneca Korea has initiated an early retirement program following the withdrawal of the diabetes treatment Forxiga from the Korean market. The company has stated that it is in discussions with the government to minimize the impact of Forxiga’s withdrawal along with its business unit restructuring. According to the pharmaceutical industry sources on the 18th, AstraZeneca Korea is currently implementing an Early Retirement Plan (ERP). Under this plan, the ERP compensation package is structured as of January 2024, with a monthly base salary*(years of service*2+8) + 130 million won. For example, an employee earning a monthly base salary of 5 million won with 10 years of service would receive an additional 130 million won on top of 5,000,000 multiplied by 28. AstraZeneca Korea’s Forxiga Forxiga (ingredient: dapagliflozin), a SGLT-2 inhibitor class treatment for diabetes, is a blockbuster drug that accumulated sales of 55 billion won in the previous year. However, AstraZeneca Korea announced its withdrawal from the Korean market in December last year. The primary reason for Forxiga's withdrawal is widely attributed to the price reduction resulting from patent expiration. AstraZeneca Korea contested the price reduction resulting from the generic listing and initiated administrative litigation against it. While the court has accepted this for execution suspension, if price reductions are implemented after February, the current price of around 730 won may drop to the 390 won range. However, as Forxiga's indications were expanded to conditions like heart failure and kidney disease, in addition to Type 2 diabetes, continued price reduction remains possible. The challenge for the company is that the price reduction in Korea can influence the price of the drug in neighboring countries, and the company cannot rely solely on sales in Korea. The price of Forxiga in Korea is known to be the lowest among OECD countries, approximately 1/40th of the price in the United States. "A decision to withdraw Forxiga takes into account various factors beyond just price. We are currently in discussions with the Ministry of Food and Drug Safety (MFDS) regarding the withdrawal and timing of domestic withdrawal," a representative from AstraZeneca Korea stated. AstraZeneca Korea to restructure business units while maintaining the sales of combination drugs. AstraZeneca Korea is also undergoing a restructuring of its business units. The current Respiratory & Immunology Business Unit and Cardio Vascular Renal Metabolism (CVRM) Business Unit will be integrated into the BioPharmaceuticals Business Unit. Following the integration, AstraZeneca Korea will operate with three units: BioPharmaceuticals, Oncology, and Rare Disease. However, AstraZeneca Korea clarified that the organizational restructuring is not because of the ERP program. According to a company representative, as part of the headquarters' strategy, existing CVRM and Respiratory & Immunology business units will be integrated into the BioPharmaceuticals Business Unit. And products like Xigduo XR Tab (Dapagliflozin/Metformin) and Sidapvia Tab (Dapagliflozin/ Sitagliptin) will continue to be part of the CVRM Business Unit's roles. For combination drugs, the extent of price reduction is not significantly greater than that of Forxiga, as there are no additional indications other than type 2 diabetes. As a result, the company may have chosen to maintain domestic sales of Xigduo XR and Sidapvia. Beginning this year, HK Inno.N will sell Xigduo XR and Sidapvia in Korea. "We believe that Xigduo XR can provide additional benefits to patients as a combination drug, and the factors taken into account were different from those for Forxiga," a representative from AstraZeneca Korea stated. The concern revolves around patients who are currently taking the active ingredient dapagliflozin and have conditions such as heart failure and kidney disease. Currently, among SGLT-2 inhibitors, only Boehringer Ingelheim's Jardiance has secured indications for heart failure and kidney disease. The withdrawal of Forxiga could potentially create challenges for patients and doctors in accessing the treatment. "The decision to withdraw Forxiga was extremely difficult for the company, considering the potential impact on patients in accessing the treatment," a representative from AstraZeneca Korea stated. "AstraZeneca Korea is actively engaged in discussions with the MOHW to find solutions that would allow patients receiving treatment for chronic heart failure and chronic kidney disease to continue their treatment.” In response to concerns about potential shortages and supply issues with Forxiga at the end of last year, a company representative said that they have secured enough of the drug. "The supply of Forxiga is sufficiently secured for this year,” the representative stated and clarifying, “Even if the approval is withdrawn, insurance code for the drug remains valid for six months, so we have secured the quantity for that duration.”
- Company
- Keytruda approved as 1st-line treatment for gastric cancer
- by Son, Hyung-Min Jan 18, 2024 04:46pm
- Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center Keytruda, a cancer immunotherapy developed by MSD, has been approved as a first-line treatment for gastric cancer in Korea. Keytruda has emerged as a new first-line treatment option, thirteen years after Herceptin (ingredient: trastuzumab) received approval in 2010. On the 16th, MSD hosted a press conference at Lotte Hotel Seoul commencing expanded indication for Keytruda (pembrolizumab) as a first-line treatment for HER2-positive gastric cancer. In December last year, Keytruda received expanded approval for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for patients diagnosed with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval of Keytruda in Korea brought a significant change in the first-line treatment options, thirteen years after Herceptin (trastuzumab) received approval in 2010. Previously, several treatment options, including lapatinib plus paclitaxel, lapatinib plus chemotherapy, trastuzumab emtansine, and trastuzumab plus pertuzumab plus chemotherapy, were tested in clinical trials for gastric cancer patients, but these treatments did not yield successful outcomes. The Phase 3 KEYNOTE-811 clinical trial, upon which Keytruda’s approval is based, demonstrated efficacy of Keytruda plus trastuzumab plus fluoropyrimidine plus platinum-containing chemotherapy has confirmed efficacy in treating gastric cancer when compared to a therapy of placebo plus trastuzumab plus chemotherapy. The results of the 38.5-month (median value) follow-up of patients with PD-L1 have shown that the Keytruda-combination therapy group acheived a median progression-free survival (PFS) of 10.9 months, which was longer when compared to the 7.3 months PFS observed in the comparison group. The Keytruda-combination therapy recorded an overall response rate (ORR) of 74.4%, which was significantly higher than the 51.9% observed in the comparison group. The Keytruda-combination therapy also demonstrated a complete response (CS) of 11%, whereas comparison group had CR of 3%. Additionally, in terms of interim analysis of overall survival (OS), the Keytruda-combination therapy showed OS of 20.0 months, whereas the comparison group recorded OS of 15.7 months. “HER2 is the only biomarker for gastric cancer,” Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center, noted. Professor Rha also said, “Previously, the rate of PD-L1 expression in HER2-positive patients had not been assessed, but the KEYNOTE-811 clinical study demonstrated that an 85% PD-L1 expression rate in HER2-positive cancer patients.” “The clinical study results demonstrating Keytruda's effectiveness in HER2-positive PD-L1-positive patients represent important data," Professor added. “To provide benefits of cancer immunotherapy, establishing a clinical framework for the dual diagnosis of biomarkers may be necessary.” Given the results indicating a high level of PD-L1 expression in patients with HER2-positive gastric cancer, there is a growing recognition of the importance of establishing a clinical framework for dual diagnosis of biomarkers to ensure that patients can benefit from cancer immunotherapy. Currently, Keytruda is approved for HER2-positive gastric cancer, while Opdivo is approved for HER2-negative gastric cancer. For the application of cancer immunotherapy in the treatment of metastatic gastric cancer patients, HER2-positive patients are mandated to undergo the 22cs assessment, while HER2-negative patients are required to undergo the 28-8 assessment. Hye Seung Lee, Professor in the Department of Pathology at Seoul National University Bundang Hospital Because of this requirement, two separate biomarker assessments may be conducted, beginning with the HER2 assessment, and followed by the PD-L1 assessment. As such, simultaneous assessment of both biomarkers could potentially improve efficiency. “If the two diagnoses were conducted separately, patients might not receive the second assessment due to the additional administrative process,” Hye Seung Lee, Professor in the Department of Pathology at Seoul National University Bundang Hospital, said. “Furthermore, performing a single tissue assessment for dual diagnosis has the advantage of minimizing tissue loss.” Another factor that could hinder patients from receiving a treatment is the time it takes to confirm whether reimbursement is applicable for dual diagnosis. Dual diagnosis falls under the New Health Technology Assessment, which typically takes up to 83 days to make a reimbursement decision after checking whether there is an existing technology for a particular drug. As a result, even if a drug is approved, it takes time for the patients to access the treatment. “Currently, once a drug’s use is approved, it may take more than a month for a patient to receive a dual diagnosis in hospitals, and patient might not receive the benefit of the treatment during the processing time,” Professor Lee explained.
- Policy
- Moderna will only supply Spikevax Duo 2 in Korea
- by Lee, Hye-Kyung Jan 18, 2024 06:07am
- Moderna Korea has discontinued the supply of all other vaccines, leaving only its latest version, Spikevax Duo 2 (elasomeran, davesomeran) in circulation among the 5 COVID-19 vaccines it had received approval for in Korea. On the 17th, the Ministry of Food and Drug Safety (MFDS) received a report on Moderna’s supply discontinuation of ‘Moderna Spikevax Inj,’ ‘Moderna Spikevax 2 Inj,’ ‘Spikevax inj,’ and ‘Spikevax 2 Inj.’ Moderna stated that it is “producing, importing, and supplying a new updated vaccine in response to the emergence of new coronavirus variants," and that it has been “supplying the latest updated version of Spikevax Inj that protects against the latest variants since October 2023.’ Moderna’s most recently updated version is called ‘Spikevax Duo 2 Inj', and its entire domestic supply is contract manufactured by Samsung Biologics. Spikevax Duo 2 Inj was granted Emergency Use Approval by the MFDS on September 27th last year for adolescents and adults aged 12 years and older against the XBB.1.5 subvariant of the SARS-CoV-2 virus. In preparation for the winter vaccination season, national regulatory agencies and international public health organizations have recommended countries update their COVID-19 vaccines to monovalent vaccines that include protection against the XBB.1.5 variant. Moderna has published clinical data confirming that its XBB.1.5 targeted monovalent vaccine provides neutralizing antibody responses to the variants BA.2.86, EG.5, and FL.1.5.1 in addition to XBB subvariants XBB.1.5, XBB.1.16 and XBB.2.3.2. The most common local adverse reaction following the use of Spikevax Duo 2 was injection site pain. The most common systemic adverse reactions were headache, fatigue, myalgia, and chills. Its safety profile was consistent with what is known for the original Spikevax vaccine. Meanwhile, Moderna has been ranked as the No. 1 domestic pharmaceutical company in terms of production volume in 2022 with its COVID-19 vaccine alone. According to the '2023 Food and Drug Statistics Yearbook', Moderna's production volume amounted to KRW 1.2756 trillion in 2022, driven by the production of 2 dosage forms of its Spikevax Inj vaccine.
- Company
- MA manager files complaint on NHIS official's abuse of power
- by Eo, Yun-Ho Jan 18, 2024 06:07am
- A controversy has arisen over the abuse of power made by an official from the National Health Insurance Service’s Department of Pharmaceutical Benefits. According to industry sources, B, a market access (MA) manager at pharmaceutical company A, filed a civil complaint with the Anti-Corruption & Civil Rights Commission’s e-People page, alleging unfair treatment from C, an official from the NHIS Department of Pharmaceutical Benefits. It was confirmed that B had attached a recording of the conversation with C with the complaint, alleging unfair treatment (abuse of power) by a public institution. It was reported that B filed the complaint through individual judgment rather than as part of company-level actions. The Department of Pharmaceutical Benefits is in charge of negotiating insurance prices of drugs with pharmaceutical companies during the reimbursement listing process. This drug pricing negotiation is a mandatory process for new drug reimbursement and is regarded as the last gateway to listing in the pharmaceutical industry. The industry has been expressing mixed views on B’s actions. "I think it was a little hasty," said one multinational pharmaceutical company’s pricing manager. “Frictions do occur and strong words are exchanged with the NHIS in the pricing negotiation process, but we are all basically partners working together for the same goal of ensuring patient access. I doubt any power play abusive enough to be reported to the e-People website would have been made in the process.” On the other hand, another representative of a multinational pharmaceutical company said, "There are definitely some people who have an overbearing attitude. Reimbursement listing is the crucial determinant of the success or failure of a drug, and the NHIS holds the key. Any wrongful actions in this crucial process should be corrected promptly."
- Policy
- Drug price cuts will be applied in bulk next month
- by Lee, Tak-Sun Jan 18, 2024 06:07am
- A number of products are expected to receive price cuts next month as a result of the second round of reevaluations the government conducted on the insurance price ceiling of listed drugs. The drug price adjustments, which were initially set to be applied in January, were pushed back to February. Also, in consideration of the returns and difference settlements that need to be made by pharmacies, sufficient time is expected to be given between the announcement and the effective date of the pricing adjustments. According to industry sources on the 17th, the second round of negotiations after reevaluation of the insurance price ceiling of listed drugs will be completed this month and be reported to the Health Insurance Policy Deliberation Committee (HIPDC). About 3,220 products were subject to the second round of negotiations. As this includes all of the evaluated items, some that are not subject to pricing adjustments are also included in the negotiations. Therefore, it is expected that the actual number of products that receive price cuts will be fewer than this. In the first round of reevaluations that were conducted in September last year, 12,800 items were subject to negotiations, but 7,400 items were applied pricing adjustments. The second round of price ceiling reassessment will cover some specialty oral drugs and aseptic drugs that were included in the bioequivalence demonstration by the Ministry of Food and Drug Safety in 2020. The second round of reevaluations included some prescribed oral drugs and aseptic drugs that were required to demonstrate bioequivalence by the MFDS in 2020. Initially, the Ministry of Health and Welfare had planned to apply the drug price adjustments in January after reporting the results to HPIDC in December last year. However, it was postponed in February due to concerns about the burden borne by pharmacies. Also, drug price ceiling adjustments following the investigation into actual transaction prices had been set to be applied in January at the time. However, this was also postponed thereafter. Therefore, the adjustment period will likely be further delayed to after March, as the results were not reported to HIPDC’s meeting this time. The pricing adjustment date for the second round of price ceiling reevaluations is also expected to be a few days after the first of next month, just as it had been in the first round of price ceiling reevaluations. In the first round, the adjustments were announced on Aug. 23 last year, notifying its implementation on Sept. 1, but the actual implementations were made on Sept. 5 to account for return and settlement confusion among pharmacies. Meanwhile, the reevaluation of the price ceiling of listed drugs is being conducted to maintain or reduce the price of listed drugs depending on whether the drug meets the requirements of self-bioequivalence testing and DMF listing. If the listed drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met.
- Policy
- Stability data requirement eased for metformin approvals
- by Lee, Hye-Kyung Jan 17, 2024 05:29am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) will change and ease the stability test submission data requirements for approvals (and changes) of metformin-containing preparation that had been strengthened following the detection of an impurity (N-nitrosodimethylamine (NDMA, NDMA). Metformin is used for the treatment of Type 2 diabetes and has been approved for 120 single-agent and 1,227 combination drug products. The government’s action follows a scientific analysis of NDMA-related stability test data that have been submitted to the MFDS to date and the conclusion that the changed data requirements are sufficient to ensure the quality of the drugs within their expiration date. The MFDS had strengthened the data submission requirements since July 2020 after NDMA was detected in metformin products to strictly control the impurity level to be lower than the standard. The stability test data required for product approval (and changes) has been strengthened to the level of new drugs. As a result, companies had to submit 12 months of long-term storage stability test data when applying for new approvals or changes to their metformin products. However, in the future, the companies will again only need to submit 6 months of long-term storage test data. The MFDS expects this improvement to help ensure the rapid development and launch of metformin products and access to treatment for patients and will continue to make the best efforts to operate Korea’s drug approval system flexibly and reasonably based on its expertise in regulatory science.
