- LOGIN
- MemberShip
- 2026-04-17 00:26:09
- Policy
- Hanmi, applied for permission for Xoterna's generic drug
- by Lee, Tak-Sun Jun 01, 2020 06:19am
- HanmiHanmi is expanding its inhaler business for respiratory diseases such as bronchial asthma and chronic obstructive pulmonary disease (COPD). In 2014, Fluterol, generic for GSK's asthma treatment was first introduced in Korea, and recently, the COPD treatment Xoterna (Korea Sandos) is also targeting the market. According to the industry on the 27th, Hanmi applied for the same ingredient as Indacaterol/Glycopyrronium on the 25th. This drug is a bronchodilator and is used as a maintenance therapy to relieve symptoms of chronic obstructive pulmonary disease. The inhalation method is to inhale by attaching a capsule-type inhalant once a day to a separate inhaler (Hanmi Heller). The original is Xoterna by Sandos under Novartis. Xoterna was licensed in May 2014. Based on IQVIA last year, sales amounted to ₩6.4 billion. Hanmi had earlier attempted a patent challenge. Last year, an invalidation trial was filed in a patent that is due to expire . Whether to enter the market will be determined based on the result of the request for the trial. So far, there have been few domestic inhalants. There are still many imported items in the market. Hanmi continues to challenge its domestic products. In 2014, it was the first domestic company to introduce Fluterol, a generic for the asthma treatment Seretide, and in 2015, it was granted Tiropium, generic for COPD treatment Spiriva. An inhaler device called 'Hanmi Heller' was also developed. However, the market performance is lower than that of the original drug compared to expectations. In the case of Fluterol, last year's sales amounted to about ₩1 billion. On the other hand, the original Seretide diskus recorded ₩12 billion. The size of global inhaler market is estimated at 40 trillion. Korea is also not small, with a size of 300 billion. According to the analysis, if localization is established in the market, which is one of the imported products, it can be a 'goose that lays golden eggs'.
- 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.
- Company
- KRPIA-MOHW talk negotiation, prioritized lisiting and PVA
- by Eo, Yun-Ho May 29, 2020 06:16am
- “Nothing was clarified, but we could somewhat feel out their approach.” For the first time since new Director Yang Yoon Seok was appointed, the Division of Pharmaceutical Benefits at Ministry of Health and Welfare (MOHW) met with a couple of dozen Korean Research-based Pharmaceutical Industry Association (KRPIA) officials and multinational pharmaceutical company market access (MA) representatives on May 28. Along with Director Yang, Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho joined the meeting, where the organization officials and various pharmaceutical company representatives freely asked questions and spoke of their recommendations. Of all topics addressed, three main issues were discussed in-depth. Is pricing negotiation required for all drugs seeking for reimbursed pricing? The Korean government has notified earlier of implementing unified drug listing procedure. For all drugs evaluated to be appropriate for health insurance reimbursement, the government has mandated negotiation to finalize the listing decision. The change is crucial for Korean pharmaceutical companies and their generic products. But for multinational pharmaceutical companies, the change is a concerning issue for the drugs taking the negotiation-exempted track with pricing lower than weighted average price. The point of negotiation exemption system is speed. Technically, companies aiming to swiftly proceed with reimbursement listing take the negotiation exemption track and choose to price the drug on the level of negotiated price. But now the mandatory negotiation procedure could slow down the listing procedure. Regarding the concern, MOWH implied its intention to operate a flexible system. MOHW official said, “The government is also aware that not all drugs seeking for reimbursement would be fit for negotiation on projected claim amount. Depending on the circumstances, the negotiation condition may vary.” Is reimbursement listing prioritization making a leeway to neglect some drugs? The new drug pricing system also stipulates the Minister of Health and Welfare to decide the prioritized order of drug reimbursement listing. Currently, the reimbursement listing review by relevant committees like Drug Reimbursement Evaluation Committee has a limited period of 150 days. But the new prioritized reimbursement review would remove the time limit. The pharmaceutical industry is clearly worried about the amendment. Basically, the reimbursement listing procedure for a drug simply pursuing the benefit could be delayed indefinitely based on the prioritized order. The government seems to be aware of the concern. MOHW explained, “Only because a drug is expensive, or in other words, the drug has a significant financial impact, it would not be ruled out from the priority order. Some drugs could start the listing procedure fast, if need be. We are always pondering on how to improve new drug access.” Price-volume agreement system and labeled price A company representative also spoke of applying the ‘labeled price’ notion, used in the risk sharing agreement (RSA) system, for drugs lowering price due to price-volume agreement (PVA) system. In fact, the government already allows PVA drugs to apply refund rate. However, the benefit is only given to the companies certified as an innovative pharmaceutical company. And the multinational company official proposed the benefit should be extended. The government officials apparently answered with a positive note. The ministry official urged, “The recommendation is plausible and we would review the matter in detail. But, as you would be aware, changes in regulations cannot be rushed in a short span of 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."
- Product
- Metformin's alternative medicine sold out in an hour
- by Kim JiEun May 29, 2020 06:16am
- As the discontinuation of sales of 31 items of Metformin used as a treatment for type II diabetes patients is decided, the shortage of alternative products is intensifying. The MFDS announced that it will temporarily manufacture, sell, and discontinue prescriptions for 31 items containing Metformin, which are used as a primary treatment for type II diabetes patients today (26). Along with the announcement of the MFDS, a notice was sent to the pharmacists of Korean Pharmaceutical Association, and pharmacists had a busy time checking the related items and organizing their inventory immediately after work. Pharmacists need to order replacement items immediately if the product they normally prepare is included among the 31 items that have been supended from today. In fact, as of 9:00 am today, Metformin alternative medicines have been rapidly sold out at major drug online malls. One of the alternatives to the metformin formulation that has been discontinued this time In the case of Glucodown OR 750mg, which were relatively prescribed in hospitals and clinics, among the discontinued items, was replaced by a pharmacy actually Yuhan’s Metformin XR 750mg, and the product was found to be sold out at major online malls less than 10 am. In addition, Yuhan’s Metformin XR 500mg 300T & 30T are currently out of stock in some pharmaceutical online malls. Pharmacists say that Daewoong’s Diabex XR is not easy to secure inventory as orders are concentrated in the morning as well as in major online retailers. A pharmacist in Seoul said, “I immediately ordered Yuhan’s Metformin as soon as I came to work today.” “Yuhan’s Metformin XR 750mg doesn't have any alternatives, so I think it will be more ordered. I know that the product is currently out of stock." Some pharmacies contacted a nearby internal medicine clinic this morning to discuss discontinued Metformin and to discuss alternative prescription products. A pharmacist in Seoul said, “I thought that Yuhan’s Metformin XR 750mg is the only substitute in a nearby hospital, but I know it is currently out of stock.” "Instead, there was a question about how to prescribe." Another pharmacist said, “It seems that pharmacists ordered quickly from online malls, etc., as information related to them was announced last night. "There seems to be some hoarding.”
- 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.
- Product
- KDA “Agree with government action on metformin with NDMA”
- by An, Kyung-Jin May 28, 2020 10:07am
- Medical academic societies expressed their support for the Korean government’s decision to suspend manufacturing and sales of metformin with excessive level of impurity found. However, the scholars noted diabetic patients should not stop taking metformin without consulting their doctors. On May 26, Korean Diabetes Association (KDA) and Korean Endocrine Society (KES) issued a joint statement on the government suspension on manufacturing and sales of metformin upon discovery of N-Nitrosodimethylamine (NDMA) exceeding an acceptable level. The statement first expressed gratitude for the Ministry of Food and Drug Safety’s (MFDS) prompt but proactive action on the metformin products and their safety issue, and also showed support for the government’s decision. The two academic societies urged, “For similar cases in the future, the government should continue to directly conduct investigation, disclose the result transparently and provide solution for the people and healthcare providers to feel free of concerns.” Prior to the statement, MFDS has disclosed 31 out of 288 metformin products available in the Korean market were discovered with NDMA exceeding the acceptable daily intake limit (96 nanograms), and halted manufacturing and sales of those 31 products. Metformin is the most widely used first-line treatment for type 2 diabetes with outstanding effect of lowering blood sugar level and many other advantages. But when Singapore’s Health Sciences Authority (HSA) announced last December that three out of 46 metformin products were found with NDMA surpassing the acceptable level, KDA has officially requested the Korean government to run a full investigation on the contamination of NDMA in metformin ingredients and finished products used in Korea. However, the medical experts stressed the government’s action should not cause a confusion for the diabetic patients using metformin. The statement advised, “31 products exceeding the acceptable limit of NDMA should not be prescribed anymore, but as MFDS has elaborated, the risk of developing cancer only from taking those products is extremely low,” and “it is not advisable for diabetic patients to stop consuming those metformin drugs without consulting their doctors, but they should rather seek for new prescription for other metformin product with safe level of NDMA.” According to the human body impact assessment by MFDS, 0.21 out of 10,000 patients, who have been taking the maximum dose of metformin product with unacceptable level of NDMA since the point of approval to the end of this year, would be risked to develop cancer. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline (ICH M7: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk) mentions the risk of developing cancer could be dismissed, if it is lower than 1 out of 10,000 people. The academic societies highlighted, “Metformin is an important drug recommended by international practice guidelines as a first-line medicine to treat patients with type 2 diabetes. And as there are nine different classes of diabetic treatments available, the government should amend the healthcare reimbursement standard to disperse concentrated use of one specific pharmaceutical substance and give various options for first-line drug based on patients’ condition.” They also added, “KDA and KES would closely cooperate with the government for enhance the health and the rights of diabetic patients, and actively participate in improving the medical system.”
- Company
- Alvogen Korea secures domestic rights for Evista
- by An, Kyung-Jin May 28, 2020 10:06am
- Alvogen Korea took over the domestic rights of 'Evista', an osteoporosis treatment for Takeda. Alvogen Korea announced on the 26th that it had obtained domestic permission for the osteoporosis treatment drug, Evista ( Raloxifene ) from Takeda Pharmaceuticals on the 25th. Evista is a second-generation estrogen receptor modulator (SERM) family and are oral drugs taken once a day. It is prescribed for the treatment and prevention of osteoporosis in postmenopausal women. At one time, sales were close to ₩15 billion a year, but sales of the complex have been plunged recently with the emergence of multiple combinations of vitamin D ingredients. According to the drug research agency IQVIA, Evista's sales last year were ₩6.4 billion. Since September 2018, Alvogen Korea has been in charge of domestic distribution and sales by signing a co-promotional agreement with Takeda Pharmaceuticals, which has domestic rights of Evista. Through this contract, Alvogen Korea has secured all rights for domestic licenses, exclusive distribution and marketing as a marketing authorization holder. Alvogen Korea announced its ambition to expand the influence of the specialized drug market by acquiring domestic rights, such as 'Seroquel', a treatment for schizophrenia, following the launch of 'Qsymia', an anti-obesity drug earlier this year. Lee Jun-su, CEO of Alvogen Korea, said, "With this agreement, we plan to firmly strengthen our expertise and market position in the field of osteoporosis treatment." "We will actively engage in marketing activities aimed at providing stable products and steady growth."
- 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.
