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- 2025-12-26 15:04:30
- Policy
- Court controversy, the price of Synovian reduction postponed
- by Kim, Jung-Ju Dec 12, 2019 06:31am
- LG Chemicals dissatisfied with the drop in insurance prices, and the price of 3 ml of Synovian (BDDE cross-linked sodium hyaluronate gel), which is fighting a legal battle with the government, is being provisionally maintained. The trial is in progress, and the court has limited the time limit from the date of the sentence to 30 days. The 6th government of the Seoul Administrative Court decided to extend on the 10th of the trial against the company (2019KuHap88095) regarding the decision that the Ministry of Health and Welfare decided to lower the price of this drug in the 'List of Drug Benefits and reimbursed Limits' (Notice 2019-254). Earlier, the Ministry of Health and Welfare decided to lower the price of medicines through the November 28 notice. Afterwards, LG Chemicals filed a lawsuit for unfair drug price cuts, and the court suspended the Ministry of Welfare's action until the first interrogation date. As a result, the price, which was supposed to be lowered to ₩ 477,041, will remain at ₩67,200 as it was until the 30th day from the date of judgment. The Ministry of Health and Welfare explained that the case is currently underway and may change depending on the outcome of the trial in the future, and they will guide you further when it changes“. No.2 is effective as of July 1, 2020, due to the suspension date. As a suspension, ₩67,200 is applied instead of ₩47,041
- Policy
- 5 years after the drug patent linkage system
- by Lee, Tak-Sun Dec 12, 2019 06:30am
- At the Four Points Hotel Seoul Guro, the 2019 Drug Forum was held under the direction of Jae-Hyun Lee, School of Pharmacy, Sungkyunkwan University (fourth from left)."There are many cases where overseas pharmaceutical companies have succeeded in using the US-licensed patent linkage system. But Korean pharmaceutical companies haven't even tried it. It's time to think about why they are not using the system". More than five years have passed since the introduction of Korean licensed patent linkage system based on the US Hatch Waxman Act with the Korea-US FTA in March 2015. The licensed patent linkage system protects the original drug patents listed in the MFDS and grants generic monopoly rights to companies that have neutralized the patents. Although there was a lot of concern that generic drugs would enter the market in the early stages of implementation, the impact on the market is less than expected. Director General, Myung-jin Chung Myung-jin Chung , head of the Korea Health Industry Development Institute, who conducted an impact assessment during the 2018 year at the Policy Forum held at the Four Points Hotel Seoul Guro, said, “Contrary to concerns over the introduction of the system, domestic pharmaceutical companies sales increased YoY due to the lack of many original companies’ ban on sales and the activation of exclusivity for generic product. The KHID's impact assessment showed that sales of generics increased up to ₩6.5 billion in 2018, and the market entry period was also shortened from 1.3 months to 4.6 months. However, there are a lot of comment that the drug patent linkage system lacks effectiveness. In the policy forum discussions, Sung-min Park, lawyer at HnL Law Office, pointed out that there were no cases of entry into the United States using the drug patent linkage system. “Even if a generic market monopoly is given through exclusivity for generic product, lower profits will be lowered if the market entry rate or market share of the latter is low during that period. In the US, the market share of late-release drugs is high in the monopoly period of 180 days, but in Korea, this is not the case, so we need to discuss how to increase the speed and market share” emphasized the lawyer. Hye-eun Shin, professor of law at Chungbuk National University, made a similar point. Professor Shin said, "There are no successful cases of entry into foreign countries by using the law, we should identify the cause and give direction". The professor added, "We need benchmarking on success cases such as Teva and Ranbak". Yoon-ho Kim, the chairman of the Korea Pharmaceutical Patent Research Society (Hanmi, Patent Team) said, “Maybe the goal was to minimize the impact when it was introduced in Korea. Now, I think that we will be a better system if we become more substantial and develop it as an opportunity for R & D development and globalize it”. In addition, the company is likely to raise the profits of items sold in exclusivity for generic product., and the MFDS, which is a related ministry, is concerned about entering the global market. Hyo-jeong Kim, Director of the Drug Management and Patent Licensing Division, said, "The way to increase the market entry rate and market share of exclusivity for generic product is deeply related to the reliability of generic drugs." "Currently, the MFDS is the most important part, and there is a part to improve awareness Kim said, "I believe that a patent case and product development technology have been accumulated through the introduction of the drug patent linkage system, so a real case study position is necessary for entering the US market." Some also suggested that the market entry period was shorter than the impact assessment results with the drug patent linkage system. Kyung-Joon Lee, head of Boryeong Pharmaceuticals, said, “If we take into consideration the fact that patents are incapacitated due to the challenges of pharmaceutical companies, we will have a much more positive number than the results of impact assessments.” “We are still unable to lag behind our competitors. There are many cases of requesting unconditional judgment without consideration, and I hope that the related laws will be revised in such a way that the positive aspects of the introduction of the drug patent linkage system can be highlighted through the impact assessment”. It was pointed out that if the patent invalidation is confirmed, exclusivity for generic product efforts will be lost. Therefore, even if it is determined to be invalid, it is necessary to improve the system so that it can be used as a right target. However, Hyo-jeong Kim explained, "There are some parts that are difficult to consider as a result of the review so far, but if you get exclusivity for generic product, you can be protected even if the patent is invalid In addition, it also defeats exclusivity for generic product challenge by intentionally deleting the patent list. Kim said, "There is a reasonable part, and we will revise and revise it". Kim said, “We will go through the process of collecting opinions by the end of this year, and we will start the legislative process for improvement plan, and we made some practical improvements and gathered opinions”.
- Policy
- 10 new rare diseases applied with special case from 2020
- by Kim, Jung-Ju Dec 11, 2019 10:20pm
- Special case insurance benefit would be applied on ten new rare diseases including adult-onset Stills disease and Kienbock’s disease from next year. Korean Ministry of Health and Welfare (MOHW) issued a revised notice on Tuesday of ‘Standard on Special Case Insurance Benefit for Individual Copayment’ reflecting the changes. The special case benefit would be applied to patients, diagnosed with one of designated rare diseases, starting from the day of hospital visit or hospitalization the diagnosis is made. The newly designated ten rare diseases are; Cryoglobulinemia vasculitis; choroideremia; Long QT syndrome; hereditary hemorrhagic telangiectasia (HHT); adult-onset Still’s disease; Kienbock’s disease; adult-onset Kienbock’s disease; X-linked ichthyosis; steroid sulfatase deficiency and X-linked ichthyosis; and infant-onset Harlequin syndrome. The changes would come in effect from Jan. 1, 2020. The ministry is to accept public opinion on the notice until Dec. 20, and finalize the changes as it is, if no concerning issue arises.
- Policy
- Kolon wins approval on inhaled schizophrenia treatment
- by Lee, Tak-Sun Dec 11, 2019 06:38am
- An orally inhaled medicine for treating agitation associated with schizophrenia is to be released in Korean market for the first time. The public’s interest is heightened by the news as inhalation powder has higher speed of body absorption and delivers effect in the shortest time. , Korean Ministry of Food and Drug Safety (MFDS) on Dec. 5 granted an approval on Kolon Pharma’s license to market Adasuve (loxapine) inhalation powder (10 mg). Adasuve is used as an acute treatment of mild and severe agitation associated with schizophrenia or bipolar disorder in adults. When inhaled with hand held drug delivery technology system ‘Staccato’, powdered loxapine is rapidly absorbed by the lung and achieve maximum plasma concentration in approximately two minutes. The drug’s administration is limited to single 10 mg dose within 24 hours. The approved label of the drug requires it to be administered only by a healthcare professional with immediate on-site access to equipment and personnel trained to manage acute bronchospasm. Developed by a U.S.-based company Alexza Pharmaceuticals, Adasuve was approved by the U.S. Food and Drug Administration (FDA) as the first orally inhaled treatment for schizophrenia in December 2012. Currently, Teva has the license to market the treatment in the U.S. Loxapine has been used for schizophrenia before Adasuve, as products like Loxapac used to be available in Korea. But now there is no other approved product with the same substance. In clinical trials with over 650 patients with acute agitation, Adasuve confirmed reduction of the condition more statistically significant than placebo. Multiple patients treated with the treatment experienced serious reaction of bronchospasm. Patients with asthma, COPD and other lung disease who inhaled the treatment were often reported with bronhospasm, and they were then treated a short-acting beta-agonist bronchodilator. The most commonly reported adverse reactions were dysgeusia, sedation and throat irritation. MFDS designated the treatment as a subject for Risk Management Plan (RMP) to continue monitor its adverse events after the commercialization.
- Policy
- What should Metformin do?
- by Lee, Tak-Sun Dec 09, 2019 06:27am
- The MFDS, which has undergone a series of Ranitidine and Nizatidine events, has ordered companies to assess the likelihood of impurity on all synthetic drug substances. Of these, raw materials and finished products with high potential for impurity detection should be tested immediately and reported to the MFDS if abnormal quantities are detected. The MFDS announced the impurity safety management plan last month. 14 days later, foreign news was reported that more than quantitative NDMA was detected in metformin. Unfortunately, this was the day of the briefing session on impurity safety management measures. So does the metformin's own research principles apply? The MFDS said it is investigating whether Singapore's raw materials that were in trouble were brought in Korea or not. The MFDS official, who met at the briefing session, also seemed to be worried enough to ask the reporter, "What should I do?“ Metformin is a pharmaceutical ingredient used as a primary treatment in patients with type 2 diabetes. It is a completely different kind of anti-hypertensive Sartan-based and anti-ulcer Tidine-based drugs that have been forbidden by NDMA. Therefore, the test method has not been correctly established in MFDS or foreign institutions. As the MFDA requires companies to conduct their own tests on substances that are likely to be impurity, the test method is ordered to use the MFDA and open test procedures for foreign regulators. However, Metformin is difficult to conduct a reliable test on its own as there is no open test method. Therefore, even if there is no domestic inflow of Metformin raw material, the MFDS seems to have to perform some tests. However, companies do not seem to be looking at the results of the MFDS' own test orders. There is no publicly available test method, but Singapore's regulators have tested it and based on the experiences established in the -Sartan and -Tidine series investigations, it is an observation that it should try its own test. Up to now, the situation is complicated. Although the FDA and the EU have investigated, until now, only the Singaporean authorities have detected NDMA in Metformin, so if there is no problem in the extended investigation, the impact on the country will be minimal. However, if NDMA is found to be more than quantitative in the expanded investigation, it is highly likely to be caught in a vortex from the domestic investigation stage. That's because Metformin's share of diabetes treatment is absolute.
- Policy
- Investigation of raw materials for Metformin in Singapore
- by Kim, Jin-Gu Dec 09, 2019 06:27am
- The three Metformin products recovered from Singapore have yet to be imported in Korea. The Singapore Ministry of Health (HSA) recently surveyed 46 locally Metformin products and recovered three of them. N-nitrosodimethylamine (NDMA) was detected above the daily allowance (96 nanograms), explains the HSA. Two controversial companies are Glorious Dexa and harmazen Medical Pte Ltd. Recovery targets are Glorious’ Glucient XR Tablet 500mg and Pharmazen's Meijumet Prolonged Release Tablet 750mg and 1000mg. In the case of Pharmazen Medical Pte Ltd, the products produced in all batches are subject to recovery. However, the Singapore Ministry of Health does not specifically explain the level or cause of detection. NDMA detection Metformin products released by the Ministry of Health of Singapore. It is confirmed that there are no imports of this drug in Korea NDMA detection Metformin products released by the Ministry of Health of Singapore. It is confirmed that there are no imports of this drug in Korea At present, there is no record of domestic imports of such drugs as confirmed by the Ministry of Food and Drug Safety. However, the drug substance of the finished drug is not confirmed. In other words, the possibility of domestic products using the same drug substance is not completely excluded. An official from the Food and Drug Administration said, “If the drug has imported in Korea, it is required to register the drug, but all three items have not been imported and ewe should contact Singapore directly, the drug substance company should be identified as early as Monday”. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) today announced that they will begin an NDMA test for Metformin preparations on Monday (local time). The direct reason is Singapore’s issue. The Singapore Health Department announced the recovery of three Metformin items four days earlier.
- Policy
- Introduction-development-turn, and the price reduction
- by Kim, Jung-Ju Dec 06, 2019 09:46am
- The pharmaceutical industry's reaction to the ambitious post-evaluation of the high-priced drugs, ambitiously issued by the government and insurance authorities, is cold. The pharmaceutical community understood the big direction of follow-up of drugs for rational fiscal expenditure, coupled with enhanced security. At the same time, it is a matter of responding to various drugs and drug prices that are popping up around the market in a way that reduces prices At the site of ‘the Public Hearing for Establishment of Post-Drug Evaluation Criteria and Methods’ held by the HIRA on the 3rd, the officials of the pharmaceutical industry censure in the plan proposed by the HIRA and the MOHW. Pharmaceutical officials who came to the public hearing did not leave after the event and contacted the insurer. The biggest problem for the pharmaceutical industry is that the re-evaluation of effectiveness (clinical utility) planned by the HIRA is a repetition of the registered contract list maintenance project from 2007 to 2011. This is a problem of overlapping hurdles, namely safety effectiveness. For governments and insurers, the market entry for licensed items and the positive gateway for payroll entry are distinctly different, but this also leads to overlapping regulations in the industry of developing and selling drugs to patients. An official of a large pharmaceutical company who attended the audience complained of fatigue, saying, “I agree with the purpose of the reevaluation, but I don't understand the results and performance of the 2011 reimbursement item’s list, and am feeling of overlapping with the application of the business at that time”. The official also said, "If the MFDS reevaluates and revokes the revoked or revised permit, anyone can agree, but we have no choice but to argue against it." There was a continuation of the question of whether the government could cover the value of drugs with a revaluation to be introduced. Another official said, “If there is no difference from the evaluation made during the MFDS approval process, and if the level of clinical literature quality evaluation is uplifted, will separate the wheat from the chaff?” “We are qualitatively evaluating the effectiveness passed by the MFDS on a document-based basis. If we don't meet the criteria, we can be perceived as an ineffective drug”. This post-evaluation also voiced the need for a social consensus whether or not the policy was appropriate for the principle of insurance in terms of the so-called 'trade off', which the government explained earlier this year. An official of the pharmaceutical industry said, “Our country is already managing the drug price in the screening system. We have already passed the validity of MFDS before entering the reimbursement”. Eun-young Park, head of the Drug Management Division, in charge of improving the evaluation of the MFDS, said, “The reevaluation of MFDS is the least effective for safety, and what we see is the framework of randomized clinical trials.” "We've improved our standards, and we want to create a clinically useful environment for how cost-effective it is to patients on the reimbursement list after screening." The industry's doubts have not eased despite clarifications that pharmaceutical companies intend not to deny the safety efficacy of drugs that they have been working hard on, but rather to see their value and adequacy. Even after the public hearing, pharmaceutical workers were seen talking about the policy in the lobby. Concerns have also been raised about foreign policy prices. It is because the evaluation criteria can be completely changed according to the will of the government, and there are also controversies and risks about how to set the comparison method and the index. The Korea Pharmaceutical Bio Association said, "It is only a reference because the government and academia are not able to confirm the actual selling price of foreign countries when talking about the new drug price controversy." "Comparing prices in eight countries" is an unreasonable attempt. " KRPIA also criticized the government's direction to lower the price of medicines to solve various issues surrounding pharmaceuticals. An official of KRPIA stressed that “the factors that determine finances are price and usage, we should ignore the focus on usage and avoid the direction that leads to drug price-oriented policies”.
- Policy
- Investing KRW 4 tn fostering Biohealth as ‘Post-semiconduct
- by Kang, Shin-Kook Dec 06, 2019 09:43am
- Until 2025, the Korean government is to assertively invest four trillion won on fostering biohealth industry as a ‘post-semiconductor industry.’ On Dec. 4, Deputy Prime Minister Hong Nam-ki led the fifth Innovative Growth Strategy meeting and the 28th Economic Ministerial meeting and discussed about next generation innovative growth engine, related validation process and additional plans. First, the government has decided to concentrate the state capability on developing biohealth industry, because new drug export volume was tripled from 1.4 trillion won in 2017 to 4.4 trillion in 2018, expanding the foundation of technology. Deputy Prime Minister Hong Nam-ki presiding at Innovative Growth Strategy meeting (middle) The government aims to grow biohealth industry as a next generation economic growth engine, or so-called ‘post-semiconductor industry’, by investing four trillion won on R&D until 2025 and developing and emerging technology. The government’s plans are to set a roadmap for biohealth regulation reform within this month to implement it from next year, and to establish human resources development center for biotechnology training two thousand experts at a time. Moreover, the government is also working on innovation strategy and plan for the service industry. The plan is to expand total service industry based on three major types of Manufacturing as a Service (MaaS), Healthcare as a Service (HaaS), and Financial Accounting Advisory Service (FAAS). MaaS is to be expanded centering a voucher program supporting companies in need of manufacturing service, whereas HaaS would develop pilot programs and validate and expand it in different regions. FAAS is to open encrypted big data of credit information provided by Korea Credit Information Services. However, the government officials expressed regret as the key regulatory reform plans for remote medicine, sharing economy and more are surrounded by fierce dispute between stakeholders and social conflicts. Specifically, the officials pointed sluggish process of revision of the three data protection laws essential for the growth of emerging industry, and that it is limiting the industries’ performance. The three information protection laws are; Personal Information Protection Act; Act on the Protection of Information and Communications Infrastructures; and Credit Information Use and Protection Act. Deputy Prime Minister stated “The government plans to foster biohealth as the next generation economic growth engine following the footsteps of semiconductor, and also it would set state-led artificial intelligence strategy, create data economy, and activate startup ecosystem for all product cycle.” “The Economic Policy Plan 2020 would contain policy focus and goals immediately in effect from next year and it would be presented to the public all together by the end of the month. To propel the innovative growth in stable and effective fashion, refining legal and regulatory foundation with legislation would be crucial,” the Deputy Prime Minister added.
- Policy
- “Providing as much clinical information for patients”
- by Lee, Tak-Sun Dec 05, 2019 06:23am
- Director Kim Jeong-mi of Clinical Trial Management Division Since the end of last October, the Korean Ministry of Food and Drug Safety (MFDS) has expanded scope of information on approved investigation new drug’s (IND) protocol uploaded on its website. Previously, only the names of clinical trial, sponsoring client, IND, targeting disease and clinical trial institute were publicly disclosed, but now more information, including comparison drug, contact information of the institute, subject selection and exemption standards are also uploaded online. Anyone can now check a company’s R&D progress in detail on the website, and patients can search information and actively participate in a clinical trial by contacting the clinical institute directly. At a press conference held on Dec. 3, Director Kim Jeong-mi of Clinical Trial Management Division at MFDS explained, “Although clinical trial information has been disclosed since 2007, we’ve been thinking that we are not meeting the patients’ expectation. We recognized the need to publicly provide similar level of information as other countries, so we formed a consultative body for clinical trial system development to specify expansion of the provided information.” “Our principle is to disclose as much information as the U.S. or EU. But the update has been slow as double-checking accurate information is taking more time than we expected,” Director Kim added. Expanding provided scope of clinical protocol information is expected to support patient’s right to know and their active participation in clinical trials. Revealing contact information of the healthcare institute was to meet the existing demands of patients seeking opportunities to participate. “These days, patients have gotten sophisticated so much to actively look for related information and to get highly knowledgeable in particular medicines. Naturally, they are curious about contact information of clinical institute and doctors in charge. Some are even eager to transfer the hospitals to participate in clinical studies”, Director Kim elaborated. Disclosed clinical protocol information has been expanded partially, but the website still lacks in system stability and promotion. Particularly because MFDS’ Drug Information System website (www.nedrug.mfds.go.kr) provides a vast amount of information on drugs, searching for IND approval status on the website takes a long time. Moreover, many people still do not realize the website provides IND information. The director said, “We still need to contemplate on how to provide the information with easier access. Also we are considering on making information search easier for IND developers and researchers.” In August, MFDS announced the Five-year Master Plan on Developing Clinical Trial System. The five-year plan aims to strengthen safety control over clinical trials and enhancing international competitiveness. Director Kim commented, “We have had a lot to ponder as transnational clinical trials have been stagnating recently and we want to create an advanced clinical environment and protocol review system in Korea attractive enough for Korean companies to develop global IND. The five-year plan has details of strengthening safety management and international competitiveness, communicating better of clinical trials and shifting public’s bias.” One of the highlights of the plan was making drug safety update report (DSUR) mandatory. The director explained, “Unlike late-phase clinical trials, earlier-stage trials have more prevalent risk of safety issue and adverse reaction. And to promote the earlier stages of trials, the ministry plans to tighten evaluation on trial sponsor and safety control on trial conductor. DSUR has been filed by multinational pharmaceutical companies, but we are also asking Korean companies to file them with the amendments.” Review on early phase clinical trials would be strengthened as well. By forming Innovative Early-phase Clinical Trial Review Team, MFDS plans to conduct overall review not only for INDs, but also on pharmacology test, quality, and statistics. “Without removing negative bias on clinical trials, Korea would struggle to acquire clinical competitiveness. We are planning to extend communication channel and to raise better awareness of clinical trials by working closely with Korea National Enterprise for Clinical Trials (KONECT) and consultative body for clinical protocol review,” Director Kim said. Nevertheless, the director stressed, “In other countries, clinical trial participation is considered as a ‘volunteer service’ with a side of treatment opportunity. But in Korea, clinical trials are regarded negatively rather than necessary. When the majority of the public can agree clinical trial is essential to the society, the need of new drug development and industrial benefit of drug development could be emphasized.”
- Policy
- Forxiga, solvate modifier applied for the first permit
- by Lee, Tak-Sun Dec 05, 2019 06:22am
- Diabetes treatment, Forxiga by AstrazenecaDomestic pharmaceutical companies have developed a solvate modified drug for the SGLT-2 inhibitory diabetic drug Forxiga (Dapagliflozin, AstraZeneca Korea) and has entered into the application process. Once approved, the market sale will be available from April 8 2023, when material patents will be terminated. According to the MFDS on 3rd, the first approval application for Forxiga's solvate modified drug was received on 26th, and the patent holder, Astrazeneca was notified according to the licensed patent linkage system. The formulations requested for approval are Dapagliflozin L-proline and Dapagliflozin citric acid. The solvate is different from the Dapagliflozin propanediol hydrate of Forxiga. In the meantime, Korean pharmaceutical companies have been trying to avoid patents by changing solvates. In particular, the efforts were made to advance the release date by avoiding the extended period of 917 days for material patents. However, the plan was out of order with the ruling that salt-modifying drugs could not circumvent material patents with extended duration. Pharmaceutical companies, except for material patents, have challenged to follow-up patents (substance 2, formulation) and received an invalid or evasion decision this year. As a result, after April 7 2023, when the patent of substance is terminated, it will be possible to market the late drug. The initial license applicants are unknown, but as many companies have been patent-challenged, concurrent licensed products are expected to be poured out through commissions. Forxiga, used for the treatment of type 2 diabetes, is the first drug to be developed as an SGLT-T inhibitor. SGLT-2 inhibitors have a mechanism that lowers blood sugar by inhibiting glucose resorption in the kidneys, thereby promoting the release of glucose through urine. Insulin-independent mechanism of action is not affected by beta cell dysfunction and insulin resistance, so it can be used in combination with existing oral hypoglycemic agents. In particular, releasing sugar through the urine has the effect of weight loss. In some cases, it is known as diabetes medication that lose weight. Because of these advantages, Forxiga is leading the new trend in the diabetic market with outpatient prescription of ₩27.4 billion last year. Currently, SGLT-2 inhibitors include Forxiga, Suglat, Jardiance, and Steglatro, all of which are new drugs. Generic drugs are blocked from market sales due to original patents.
