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- 2026-05-08 22:55:00
- Policy
- Novartis filed a lawsuit for Galvus’ salt-altering drug
- by Lee, Tak-Sun May 29, 2020 06:17am
- It was confirmed that Novartis has filed a lawsuit against the MFDS regarding the approval process of 'Vildagle 50mg' (Vildagliptin HCl), a DPP-4 series diabetes treatment drug that was approved in January. Unlike the Novartis’ Galvus (Vildagliptin), Hanmi's Vildagle is a salt-altering drug with HCl. In addition, Vildagle's indication doesn’t include co-administration with Sulfonylurea or Metformin or Thiazolidinedione monotherapy if blood sugar control is not available. According to the industry on the 28th, Novartis recently filed a lawsuit against the MFDS for request for suspension of execution and cancellation of item permission, saying that Hanmi was granted permission in violation of the obligation to notify the application for permission under the drug patent linkage system. According to the licensing patent linkage system introduced in 2012, generic companies must notify the patent holder of the application for permission. The patent holder may dispute this, and the manufacture and marketing of generics may be suspended for nine months. Novartis claims, however, that Hanmi failed to comply properly even though it was obliged to notify generic licenses. However, Hanmi argues that Vildagle was not obliged to notify, as he was granted permission without an indication that the patent is currently in existence. The MFDS also said that there was no obligation to notify Vildagle as it is not related to the patent rights that exist. Currently, Hanmi has been requesting a judgment to confirm the passive scope of rights that Vildagle has evaded Galvus’ patent rights (expired on March 4, 2022). The judge is expected to come to trial in June as soon as possible. Novartis said that the MFDS and Hanmi went through the permitting process, assuming Vildagle’s patent evasion, before the trial of the Judge was issued. Novartis has also filed a disposition to prohibit the sale of Vildagle to Hanmi. Vildagle 50mg received a price of ₩403 per tablet in April, so it was ready for release. If the court accepts the Novartis’ claim and cites the suspension of the item license for Vildagle, it is expected that the rights such as market sales will be deprived for a certain period of time. In addition, if Novartis wins the main lawsuit, it is expected to cancel the item license. However, as the MFDS claims that the item approval process was normal, the final ruling is expected to take a long time.
- Policy
- KAPO-HIRA on Lutathera coverage “Shooting for September”
- by Lee, Jeong-Hwan May 29, 2020 06:16am
- A patient group announced a meeting was convened with Health Insurance Review and Assessment Service (HIRA) Pharmaceutical Management Department to talk about granting healthcare reimbursement on Neuro Endocrine Tumor (NET) treatment Lutathera. The group is demanding the Korean government to take into consideration of the patients reluctantly travelling afar to receive treatment in Malaysia amid COVID-19 pandemic for more reasonably priced option. HIRA plans to accept the patient group’s demand as much as possible and to issue revised Lutathera coverage status notice on Sept. 1. On May 27, Korea Alliance of Patients Organization (KAPO) disclosed the outcome of their meeting with HIRA Pharmaceutical Management Department. KAPO official reported HIRA is fully aware of patients’ agony of inevitably paying for expensive Lutathera as COVID-19 pandemic has blocked them from the overseas treatment the patients received despite the reported cases of medication misadventure. The officials elaborated Novartis is not applying for reimbursement listing, although Ministry of Food and Drug Safety (MFDS) has asked for Novartis Korea’s listing application through approval-reimbursed pricing evaluation linkage system after completing Lutathera’s safety and efficacy review. Moreover, HIRA is currently reviewing National Health Insurance (NHI) reimbursement standard on Lutathera. However, HIRA has reportedly expressed concern over pharmaceutical companies abusing the NHI reimbursement exceptionally granted on urgently approved orphan drug. But as a conclusion, HIRA said the agency would strive to issue the revised Lutathera reimbursement notice on Sept. 1. KAPO pointed out, “HIRA and Novartis should promptly proceed with the reimbursement listing procedure to lessen the burden of NET patients struggling with overseas treatment and high-cost drugs.”
- Policy
- A market return track is needed for NDMA-related drugs
- by Lee, Jeong-Hwan May 29, 2020 06:16am
- The production and sales of Valsartan, Ranitidine, and Metformin have been discontinued due to the detection of NDMA (N-nitrosodimethylamine), a carcinogen, and prescriptions have been limited, and people's anxiety and the blow to the pharmaceutical industry are increasing. In particular, while NDMA detected in Valsartan in the past was identified as a Chinese raw drug, NDMA in Ranitidine and Metformin are said to be 'fighting against invisible enemies' in the pharmaceutical industry without knowing the exact cause. Therefore, the view of the pharmaceutical industry says that the government should not focus solely on the ban on the sale of impurity drugs, but should establish a regulatory measure to return the drugs that have been proven to be harmful to the market, so that NDMA detection can soon erase the stigma of permanent withdrawal from the market. 23 pharmaceutical companies with 31 items of Metformin diabetic drugs that were manufactured and discontinued on the 26th are busy with follow-up measures according to government announcements without prior notice. Their worries are how to find the cause of NDMA detection beyond basic administrative measures, such as the recovery of distribution drugs, and how to seek survival measures for drugs that are prohibited for sale. In particular, pharmaceutical companies with high impact are JW-Pharma and Hanall,, which prescription amount of ₩10 billion is banned. Last year's prescription amount of Guardmet (100/1000mg,100/500mg, 100/850mg) by JW-Pharma was ₩9.7 billion. Prescriptions amount of Glucodown OR (500, 750, 1000mg) by hanall was ₩ 8 billion over the same period. With three consecutive NDMA detection bans occurring, pharmaceutical companies are sympathizing with the MFDS' prompt response, but are also urging them to make efforts to prepare for a resurgence of the bans. The MFDS announced that suspension of manufacturing, sales and prescription for 31 items of Metformin would be discontinued, and the possibility of developing additional cancer was negligible. Specifically, the MFDS estimates that the likelihood of developing additional cancer in patients taking the item is 0.21 out of 100,000, and said "the risk is very low." The ICH (International Drug Regulatory Organization) guidelines evaluate the level of negligibility in cases where there is less than one out of every 100,000 cancers. In particular, the FDA estimated that the cause of the NDMA detection occurred in the manufacturing process of the drug rather than the raw drug. Therefore, some of the pharmaceutical industry is arguing that there is a need to upgrade the regulation method of NDMA detection drugs compared to the existing ones. It is to ask for regulations to be manufactured, sold, and prescribed again after the forbidden drugs meet the safety and risk criteria. Currently, the MFDS analyzes the cause of NDMA detection and confirms that there is no need to reoccur in the manufacturing process, and then meets the three conditions for recovering the entire quantity of the problem in question, allowing it to be banned and re-released. The time it takes to meet this condition is about 10 months in the past when comparing to the situation in Valsartan. Even if the prescription is discontinued in the prescription market for only one month, the prescription drugs suffer the same level of damage as leaving the market. The pharmaceutical industry claims that if it takes 10 months to re-release a prohibited drug, it is actually a fatal condition that cannot be returned to the market. Accordingly, the pharmaceutical industry is not inadvertently manufacturing and selling the drug itself that exceeds the NDMA provisional management standard of the MFDS, but requires that 'Pincette regulation' in which the drug is applied only to the lot detected after the investigation of the items in question. In this case, the pharmaceutical industry believes that not only can the pharmaceutical industry's NDMA povia be partially resolved, but also the fear of vague drug impurities in the public can be relieved. An official from a pharmaceutical company in Korea said that it is necessary to consider not to ban or recover all NDMA-detected drugs, but to go through detailed inspections to ban sales of exceeding standards. Ironically, the MFDS pointed out that it is distributing a press release saying that the hazard level is 0.21 per 100,000 people, which is negligible. An official from domestic pharmaceutical company B explained that after confirming the impurity detection, all items to be produced and shipped after NDMA inspection have been shipped, and products with a lower than the standard value are released, but the lot number exceeding the standard is prohibited and sold, if that is difficult, the burden of pharmaceutical companies will be reduced by creating a procedural track that allows forbidden drugs to return to the market after meeting safety standards. The official said, "The NDMA situation has continued with Valsartan, Ranitidine, and Metformin, and impurities have emerged from multi-drug drugs of various diseases. Some of the drugs that have been taken this time have been below the standard in the pharmaceutical company's self-examination." "If we ban all sales at all times, the stigma of drug and drug companies will be repeated."
- Policy
- Bayer’s NUBEQA was approved by the MFDS
- by Lee, Tak-Sun May 28, 2020 10:08am
- Another prostate cancer drug, Bayer's Nubeqa, was approved in Korea. On the 27th, the MFDS approved a new drug for Bayer Korea's 'Nubeqa 300mg' (Darolutamide) as a treatment for patients with non-metastatic castration-resistant prostate cancer(nmCRPC). Darolutamide, the active ingredient, is a nonsteroidal antiandrogen (NSAA), and acts as a selective antagonist of the androgen receptor (AR) by directly binding to a receptor ligand binding domain with high affinity. It also competitively inhibits androgen binding, androgen receptor nuclear translocation and androgen receptor mediated transcription. In particular, it has a strong in vivo anti-tumor efficacy (reduction of tumor cell proliferation) and thus has a mechanism of reducing tumor volume in a xenograft model of prostate cancer, including a castration-resistant model overexpressing androgen receptors. In a Phase III clinical trial (ARAMIS) of 1,509 high-risk nmCRPC patients, the drug demonstrated a statistically significant improvement in metastasis-free survival (MFS) compared to placebo. The median survival period was 40.4 months for the Nubeqa group and 18.4 months for the placebo group. In addition, the overall survival (OS) and time to pain progression compared to placebo were also delayed. Nubeqa obtained FDA approval in July of last year, and was released to the Japanese market on May 26th. When Nubeqa is released in Korea, it will likely compete with Astellas' Xtandi, which has the same indications. Xtandi signed a risk-sharing contract with the NHIS in November 2014, and last year's IQVIA sales amounted to ₩23 billion. Other prostate cancer treatments include Pfizer's Zytiga and Janssen's Erleada, which has not yet been approved in Korea.
- Policy
- The MFDS suspends sales of 31 items of Metformin
- by Lee, Tak-Sun May 28, 2020 10:06am
- As the MFDS temporarily suspends manufacturing, selling, and prescribing 31 items containing Metformin, which are being used as the primary treatment for patients with type II diabetes, the issue of impurities in pharmaceuticals is expected to re-occur. However, due to the same NDMA issue, 175 Valsartan products and 269 Ranitidine were discontinued, but 31 of all the Metformin were discontinued, thus there was no major confusion in patient prescriptions. Only 31 out of about 288 items are discontinued, alternative medications are sufficient. According to the industry on the 25th, the MFDS has released a safety bulletin containing 31 items (22 pharmaceutical companies) of Metformin preparations that exceed the provisional management criteria of the carcinogenic substance N-nitrosodimethylamine (NDMA), and discontinued the prescription. As a result, it was reported that the items had been suspended from 00:00 on the 26th. Although the details are not yet known, the MFDS explains that 31 out of 288 finished products in circulation in Korea exceeded the NDMA provisional management standard. As of the 25th, there were only 672 approved items containing metformin. Of these, replacement items are sufficient in that only 31 items have been discontinued. In September of last year, 269 items of Ranitidine, a gastric ulcer treatment drug that NDMA was over-detected, were banned from sales, and there was great confusion in the medical field, such as replacing prescriptions with other ingredients. On the other hand, Metformin formulation is expected to be easily replaced with products of the same ingredients, as there are relatively few items forbidden to sell. Nevertheless, this is the strongest action among countries worldwide. Metformin's NDMA issue broke out on December 4, last year, when the Singapore Health Sciences Authority (HSA) recovered three products. HSA said three out of 46 items of Metformin on sale detected NDMA above the daily allowance. Subsequently, three pharmaceutical companies in Canada decided to voluntarily recover Metformin preparations, and in February, Ranbaxy in India began voluntarily recovering six lots of two products. However, The U.S. Food and Drug Administration (FDA) did not take any action when it surveyed 10 items in February and found that a small amount of NDMA was detected in two products. The European Medicines Agency (EMA) has not yet released an official position. Investigation over a long period of 5 months from 900 raw materials to finished products After a problem in Singapore, the MFDS identified the manufacturer of the raw material in question in exchange with HSA, and immediately went into the investigation into the drug substance. The MFDS said it was investigating raw materials for more than 900 products at the time. Starting in April, the drug investigation began. The survey targets appear to be 288 finished products in circulation in this letter. Some people say that NDMA exceeded the tentative standard in products using some Indian raw materials. Experts have claimed that Metformin preparations are used as the primary treatment for patients with type II diabetes, so be careful with NMDA measures. Therefore, the MFDS seems to have conducted a long-term investigation for 5 months for screening. However, if detailed items are released, the pharmacy will be confused again with problems of return, exchange, and recovery.
- Policy
- PVA lowers Entresto and Synovian pricing
- by Kim, Jung-Ju May 27, 2020 06:04am
- The prices of Novartis Korea’s Entresto film-coated tablet (sacubitril plus valsartan plus sodium salt hydrate complex) and LG Chem’s Synovian injection (BDDE bridged sodium hyaluronate gel) have been negotiated to be lowered by 7 percent and 2.7 percent, respectively, due to their increased use. Daewoong Pharmaceutical, Ildong Pharmaceutical and Amgen Korea voluntarily requested to lower the prices of their Gliasta soft capsule (choline alfoscerate), Pirespa (pirfenidone) 200 mg tablet and Blincyto (Blinatumomab) 35μg injection, respectively. Korea’s Ministry of Health and Welfare (MOHW) has recently finalized the revised ‘List of Reimbursed Drugs and Maximum Reimbursed Price’ with the changes mentioned above. The new list would come in effect from June 1. First, Novartis Korea has negotiated with National Health Insurance Service (NHIS) over Entresto film-coated tablet according to the Type Ga (가) of the price-volume agreement (PVA) system. The Type Ga applies on an item listed with pricing negotiation, when the claimed amount has exceeded the amount projected from the point of negotiation by 30 percent. The item’s claimed amount is calculated from the claims made under the same supplier, administration method, active ingredient and form of the item. The tablet’s reimbursed price would be reduced by 7 percent from 2,200 won to 2,046 won. The dose varies from 50 mg to 100 mg and 200 mg, but the same price is applied to all. LG Chem’s Synovian injection, for instance, was negotiated for pricing reduction under Type Na (나). An item that has been listed for over four years without pricing adjustment by Type Ga PVA, but the total claim amount has surpassed the projected amount at the point of listing by 30 percent. For such items, NHIS negotiate with the supplier depending if the claimed amount has surpassed 60 percent more than the previous year’s amount, or the increased amount has surpassed over 10 percent and adds up to over 5 billion won. The injection’s price, effective from next month, would be brought by 2.7 percent from 67,200 won to 65,400 won. Pricing of total six items would be reduced due to preliminary price reduction based on additional indications. The government preemptively lowers price of an item with extended indication by taking account of additional claim projection and increase rate. The six items include Pfizer Pharmaceutical Korea’s Benefix (Recombinant Blood Coagulation Factor Ⅸ) injection in five doses and AstraZeneca Korea’s Faslodex (fulvestrant) injection. The price of Benefix injection in 250 I.U, 500 I.U and 3000 I.U would be lowered from 789 won to 777 won, and the injection in 1000 I.U and 2000 I.U would be lowered from 788 won to 776 won, all by 1.5 percent. Faslodex injection’s price would be lowered by 5 percent from 567,595 won to 539,215 won. Three items have voluntarily requested for pricing reduction. The government adjusts the maximum price as requested, when a drug manufacturer, CMO or importer requests for the pricing lower than the listed maximum price. Daewoong Pharmaceutical’s Gliasta soft capsule (choline alfoscerate) pricing would be bought down by 0.4 percent from 508 won to 506 won, and Ildong Pharmaceutical’s Pirespa (pirfenidone) 200 mg tablet pricing would be lowered by 0.3 percent from 3,304 won to 3,294 won. Amgen Korea’s Blincyto (Blinatumomab) 35μg injection pricing would be reduced by 5.2 percent from 2,346,000 won to 2,223,503 won, effective from next month.
- Policy
- Benefit of COVID-19 medications completed in just one day
- by Lee, Hye-Kyung May 27, 2020 06:04am
- In order to prevent the spread of COVID-19 infection, the HIRA is the one which is drawing attention. The DUR system was used to help medical institutions check immigration visit information from around the world, and it shortened the review period for drug benefit standards that took more than 80 days on average to one day, promptly resolving the benefits of COVID-19 treatment. Medicines that are approved for treatment of COVID-19 beyond the scope of the permits include Interferon (including pegylated interferon), Kaletra (Lopinavir/Ritonavir), Hydroxychloroquine, Ribavirin, Immunoglobulin G, Oseltamivir ,Zanamivir, etc. Based on the latest medical experience and expert recommendations, the HIRA decided to review the health insurance standards for COVID-19 related therapies in the shortest period (1 day) and review the reimbursement standards for these drugs one year later. In addition, the HIRA is in charge of managing the distribution and usage status, such as monitoring the current status of treatments and providing them to medical institutions and pharmacies. In addition to pharmaceuticals, the support of the HIRA for the treatment of COVID-19 includes the dispatch of 181 specialists, rapid application of diagnostic tests (average from 30 to 60 days → shortened to 2 days), quarantine treatment· emergency medical services·National Security Hospital·fee for phone consultations. The government also provided support for the development of government guidelines (announcements), development and provision of patient guidelines for living treatment centers, financial support for medical institutions, and policy materials. In particular, the mask purchase confirmation system, which enables the sale of day-of-day masks to check public information on the purchase history of masks and lead fair distribution by using a medical institution business portal connected to pharmacies, was evaluated to have played a major role in preventing the spread of COVID-19. In this regard, Kim explained that the mask purchase confirmation system is a marvelous program in the world, and the HIRA has been using the existing information and communication channels to make it easier and fairer for people to buy masks. Earlier in the occurrence of COVID-19, the HIRA announced the visitor information from all over the world by monitoring foreign immigrants and using the DUR · ITS system connected to medical institutions. and helped them establish the movements of the confirmed patients and connect them to 1339. The HIRA's efforts were introduced in the 'OECD Health Care Quality and Outcome Working Group', chaired by Sun Min Kim, president of the HIRA. The HIRA currently releases COVID-19 confirmed patients’ data to authoritative academia and government agencies around the world (applied to 1,232 people in 55 countries), provides the basis for diagnosis and patient treatment by physicians, and makes policy decisions such as prevention through case analysis. President Seon Min Kim said that he had been busy responding to COVID-19 since taking office, and emphasized that the HIRA has worked extensively to prevent early detection, treatment, and spread of COVID-19. He said that while suffering a global disaster called COVID-19, everyone is paying attention to how good the Korean health system is.
- Policy
- Ultomiris, a successor to Soliris, was approved in Korea
- by Lee, Tak-Sun May 27, 2020 06:04am
- Handok acquired a domestic item license for paroxysmal nocturnal hemoglobinuria (PNH) treatment 'Ultomiris'. Ultomiris is a product that was expected as a successor to Soliris, and is a drug developed by Alexion, like Soliris. In particular, it has attracted attention in that it has increased convenience by significantly reducing the number of doses than Soliris. On the 21st, the MFDS approved a license for Ultomiris (Ravulizumab) by Handok as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) in adults on the 21st. Ultomiris is a drug approved by the U.S. Food and Drug Administration (FDA) in December 2018 and the European Medicines Agency (EMA) in July 2018. In Korea, a phase III clinical trial has been conducted in 8 patients. PHN disease is a rare, life-threatening blood disease characterized by the destruction of red blood cells by complement system, which is part of the immune system. In particular, 4 out of 10 people die within 5 years if not treated after diagnosis. It is known that there are about 200 patients in Korea. Soliris (Eculizumab, Handok), which was released in Korea in 2012, is the only treatment for PHN, and patients treated with Solis showed a 5-year survival rate improved to 95.5%. However, the price is expensive. In Korea, the insurance price is applied to ₩5.13 million per bottle. Accordingly, the total annual sales of the administered patients amount to at least tens of billions won. As of IQVIA, Soliris sales last year were ₩43.8 billion. The industry believes that the expected sales will be high if 'Ultomiris', a follow-on drug with improved administration frequency, is also released. Ultomiris is a drug that can be administered as a maintenance dose once every 8 weeks from 2 weeks after the initial dose. On the other hand, Soliris should be administered a maintenance dose every two weeks. It is expected that patients suffering from injections will be reduced as Ultomiris significantly reduces the number of doses than Soliris. Since it is a very expensive drug, it is expected to focus on negotiating a price with the government after the approval.
- Policy
- Chloroquine was approved for export due to COVID-19
- by Lee, Tak-Sun May 26, 2020 06:06am
- #iUnder the influence of COVID-19, the approval of Chloroquine for export used as a therapeutic agent has been followed. It seems that domestic pharmaceutical companies are targeting overseas exports and making items due to the worldwide pandemic phenomenon. According to the MFDS on the 25th, permission to Chloroquine and Hydroxychloroquine for export reached 12 items in five companies this year. Starting with Korea Prime Pharm, on the 4th, CTC Bio, Korea United Pharm, Ahngook Pharm, and Unimed have obtained export licenses. They seem to have been granted permission for the purpose of developing and exporting formulations by importing raw materials from overseas. An industry official said, "The MFDS' export permits simply by the documentation." Countries that require Chloroquine will be licensed for export, and later approved by local countries. " In Korea, 27 items have already been approved, so there is no problem with the supply and demand of Chloroquine. However, companies believe that there is a high likelihood of a treatment gap in a sudden infectious disease abroad, especially in developing countries. Chloroquine has been used since the early days of COVID-19 along with Kaletra ( Lopinavir + Ritonavir), an AIDS treatment, and is in high demand as it is encouraged in some countries. Although this agent is used for the treatment and prevention of malaria, it is used as the primary treatment for COVID-19 in the medical field. In Korea, the Central Clinical Committee recommends Chloroquine as a standard treatment through literature review, and thus Hydroxychloroquine is used. However, there is a controversial situation about the actual effect. Trump believes Hydroxychloroquine could be a "game-changer" against the coronavirus, there are reports that the death rate has increased. On the other hand, other studies have shown that there are few side effects and there is an actual effect of preventing COVID-19. Nevertheless, it is an analysis that demand from overseas countries is increasing. PMG Pharm decided to export about 2 million dollars worth of Hydroxychloroquine to South America. CTC Bio, which has been granted permission for export, said, "The global demand has surged, so there are a lot of needs in existing countries as well as in overseas customers." It is known that domestic pharmaceutical companies are considering exporting not only Chloroquine, but also generic for Kaletra. Kaletra, in particular, has opened up opportunities for generic companies as Abbvie, the original developer, abandoned the patent. It is said that some domestic companies are currently pursuing export licenses while importing raw materials from India and developing formulations.
- Policy
- Will Vyleesi known as Viagra for women be released?
- by Lee, Tak-Sun May 26, 2020 06:05am
- A product known as Viagra for Women conducts clinical trials in Korea. It is Vyleesi (Bremelanotide, injection type) introduced by Kwangdong Pharmaceutical. The MFDS approved a clinical trial phase III bridging study plan by Kwangdong Pharmaceutical on the 22nd. Bridging study is a test to prove whether new drugs developed in foreign countries have the same effect on Korean people. Vyleesi conducted a phase III clinical trial in 1,267 premenopausal women who were diagnosed with underactive sexual desire disorder in the United States after being approved by the US FDA in June last year. At the time, the clinical results showed an effect in improving sexual desire and reducing pain associated with low sexual desire. The clinical trial will verify whether this effect is the same for domestic patients. The domestic patient population is 146, and is limited to pre-menopausal women with or without hypoactive sexual desire disorder (HSDD). The clinical trial will be conducted at Korea University Hospital in Seongbuk-gu. In 2017, Kwangdong Pharmaceutical signed a license agreement with Palatin Technologies, an American developer of Vyleesi, and obtained a sales right in Korea. The drug is a disposable pen-type subcutaneous injection, which is self-administered medication. The company has passed the bridge study and aims to release it in Korea around 2022. An official from the company said, "We expect Vyleesi to greatly contribute to improving the quality of life for women."
