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- 2026-04-16 04:58:38
- Company
- Samsung-AZ joint venture contemplates on Mabthera biosimilar
- by Kim, Jin-Gu Oct 22, 2020 06:30am
- Mabthera product image. A subsidiary of Samsung Biologics, Archigen Biotech (“Archigen”) has successfully completed clinical trials but it has not yet disclosed its further plan on the product in development. While Archigen’s sole portfolio is a Mabthera (rituximab) biosimilar in development, the industry is paying attention to the correlation between Archigen’s silence and the saturated Mabthera biosimilar market. A source from the pharmaceutical industry told on Oct. 19, Archigen has completed a Phase III trial on 'SAIT101' treating patients with follicular lymphoma and published the outcome. The study was conducted in the U.S., Europe, Japan and South Korea. According to the clinical trial information website ‘ClinicalTrials.gov’ managed by the U.S. National Institutes of Health (NIH), the study started from June 2016 and ended in last January. The outcome of the study was presented in last August after data analysis. The trial had total 315 participating patients with follicular lymphoma, in which 158 patients were treated with Mabthera and the rest of 157 patients treated with SAIT101. The outcome seemed generally successful. The primary endpoint, overall response rate (ORR) in the Mabthera group marked 70.6 percent and the SAIT101 group marked 66.3 percent. Prior to the disclosure, a Phase I trial outcome comparing the Korean-made biosimilar against Mabthera in treating rheumatoid arthritis was published in last February. The outcome was also deemed successful as the biosimilar’s efficacy was on par with Mabthera. Disclosed information on Archigen’s Phase III trial on SAIT101 treating patients with follicular lymphoma (top) and Phase I trial on treating rheumatoid arthritis (Source: ClinicalTrials.gov) However, the company has not spoke of any prospective plan on the drug for two months and even for eight months. The industry sources say it is an exceptional case. Usually, a company would announce additional clinical trial or item approval plan around the point of announcing the clinical trial result. Archigen’s parent company, Samsung Biologics gave an explanation in principle only. The company official said, “We would have an opportunity in the future to speak of the prospective plan.” Archigen is a biosimilar-specializing company established in 2014 as Samsung Biologics and AstraZeneca’s joint venture with 50/50 partnership. With that in mind, the South Korean company would not be able to make a prospective plan by itself. Regardless, the pharmaceutical industry has a different view in why Archigen is contemplating for a long time. It is a convincing story that SAIT101, as a latecomer, would not have a favorable position entering the market. At the moment, Celltrion, Pfizer and Sandoz are having a heated competition in the Mabthera biosimilar market. In the European market, Celltrion’s Truxima, Sandoz’ Rixathon, and Pfizer’s Ruxience have been released. And due to the series of biosimilars launched in the market, the original Mabthera’s sales have been halved. Meanwhile, Sandoz has decided to pursue sales in the world’s biggest market, the U.S. with low marketability expected. The industry experts analyze the company felt the strain to enter the market after Celltrion promptly expanded its market share. When launching its latecomer drug Ruxience in the biosimilar market, Pfizer lowered 15 percent of Truxima’s price. On the contrary, some claim Samsung Biologics and AstraZeneca would push ahead with the product launch to retrieve the investment made so far, worth approximately 250 billion won. A pharmaceutical industry source explained, “The Mabthera biosimilar market is a tough one as even Sandoz, considered as the biggest competitor of Celltrion, backed out from the U.S. market and Pfizer also had to lower the price of its follow-on drug by 15 percent,” so “Samsung Biologics would have to make a difficult decision to break through the challenging market.”
- Policy
- Competition for generics for Tenelia M SR is fierce
- by Lee, Tak-Sun Oct 21, 2020 06:35am
- Tenelia M SR Following Handok's DPP-4 inhibitory diabetes treatment 'Tenelia', the generics for 'Tenelia M SR', a combination drug combined with Metformin, are also actively developing commercialization. According to the MFDS on the 20th, this year, Kyung Dong and Kolmar Korea were approved for a phase I clinical trial to compare the equivalence of their developed drug and Tenelia M SR. Kyung Dong received approval of two clinical trial protocols in July and August, and Kolmar in August and October. The reason for the two trials is that Tenelia M SR is a drug that controls blood sugar both before meal and after meal by taking once a day. Therefore, Kyung Dong and Kolmar Korea conduct a test to compare the bioequivalence of healthy adults in two situations before and after meals. Previously, Mothers Pharm was also approved for clinical trials in two situations before and after meals in October last year. Until now, Tenelia salt modification single drug product approval and application for permission are continuing, but it is known that there is no approval procedure for the combination drug Tenelia M SR. It is still in the stage before commercialization. A single drug was applied for the first approval of a product containing Teneligliptin HCl, a salt-modifying drug, in April, and Kyungdong received the first approval of 'Teneritin Tablet 20mg' with the same ingredient last month. In addition, five additional Teneligliptin HCl hydrates have been applied for permission, and two cases of 'Teneligliptin tosylate hydrate'' have been applied for permission. Both drugs were reportedly developed by Kyung Dong and Mothers Pharm. The ingredient name of Tenelia is Teneligliptin hydrobromide hydrate. Teneligliptin's substance patent expires on October 25, 2022, so generics cannot be sold until then. In addition, a separate composition patent for Tenelia M SR is scheduled to expire on December 23, 2034. There are still no generics for composition Patent. Tenelia is a product introduced by Handok by 'Mitsubishi Tanabe Pharma' in Japan. However, Tenelia M SR is a product developed by Handok as a combination drug after the introduction of Tenelia. The combination drug Tenelia M SR outperforms the single drug Tenelia. Based on UBIST, Tenelia M SR's outpatient prescriptions in the first half of this year were ₩10.8 billion and Tenelia’s sales were ₩9.5 billion.
- Opinion
- [Reporter’s View] Investors’ money, who is it for?
- by An, Kyung-Jin Oct 21, 2020 06:33am
- The public is giving the cold shoulder to the South Korean bio companies and their recent investments. A number of bio companies have apparently invested in Optimus fund that caused loss of about 500 billion won from an alleged fraud. And as the public found out about the fraud, the bio companies could not avoid their harsh reproach. Once valued at 5 trillion won, Helixmith came under fire from the investors as it was uncovered to have invested a large sum of over 200 billion won. This is not to criticize a private company investing on a high-risk hedge fund. Like any other individual investors, companies can carry out diverse investment models to multiply their assets. However, the problem is that these companies have injected a part of their investors’ money, received to improve R&D and relevant facility, to the high-risk hedge fund. The criticism on their ‘moral hazard’ would be inevitable, when they technically ‘gambled’ with the shareholders’ money. Most of the listed bio companies source their finance from the stockholders as they increase capital by issuing new stocks. Many of them generate insignificant sales volume, but they raise capital by ten-fold of the sales profit from the shareholders’ investment. For instance, Helixmith’ annual sales profit marked around 4.5 billion won last year, but it offered new stocks worth of total 281.7 billion won to the shareholders last month. Their plan is to secure over 60 times of their annual sales as capital by simply asking for investors’ money. The same company has also received total 300 billion won from increasing paid-in capital twice, each in 2016 and 2019. Superficially, their objective of follow-on offerings to the shareholders is to develop new drug. To let the shareholders to invest the finances for the new drug development, those companies would offer an opportunity to buy new stocks for inexpensive price. But a large-scale paid-in capital increase is not good news for the shareholders. Typically, the value of the stock gets diluted and drops when the rights issue is announced. For the shareholders, who cannot buy new stocks with their tight financial situation, the company’s decision to issue more stock cannot be pleasant. Also, the participating shareholders would have to take in even worse damage, if the stock value falls further after the rights issue. Whenever a company is offering a large-scale rights issue, the company has to report in detail regarding a specific objective of using the injected capital. The companies usually state the additional capital would be used on achieving the company’s vision like in new drug R&D, production facility expansion and debt repayment. A company receiving finances from investors is making a promise with the investors. The investors give their capital to the bio companies, believing that the executives of the companies would reach the vision as proposed. Statistically speaking, not all bio companies would be able to get to where it intended. The South Korean investors have also learned of difficulties the companies have to undergo in recent years. In the end, their hopes and dreams of a successful new drug leveraging the company as a global company lead the investors and the company executives to continue invest in R&D. A company instigating investment by manipulating the investors cannot be tolerated—it would disturb the order in the stock market. We would have to be concerned of certain company executives’ moral hazard influencing the investors’ distrust in the bio industry.
- Policy
- Sneak peek into NHIS-HIRA audit centering new drug coverage
- by Lee, Jeong-Hwan Oct 21, 2020 06:32am
- An independent Lawmaker Lee Yongho (left) and People’s Power Party Lawmaker Lee Jongseong The National Assembly annual audit for National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) scheduled on Oct. 20 is predicted to address the issue of improving patients’ coverage on new drugs like high-cost anticancer treatment. The lawmakers would likely to talk about the necessity of legislating ‘pre-listing reimbursement and post-evaluation’ on rare disease treatments and establishing ‘cancer fund’ for cancer patients’ improved coverage. A renowned expert in immunotherapy, Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital, would be summoned as a witness to speak his opinion on new drug access and catastrophic medical expense. On Oct. 19, many of the lawmaker of the Health and Welfare Committee were reportedly preparing the audit agenda regarding the access to new drug. Particularly, an independent Lawmaker Lee Yongho and People’s Power Party Lawmaker Lee Jongseong are focusing on the financial impact burdened on patients using non-reimbursed and expensive anticancer treatment. In fact, the two lawmakers have been engaging with various activities in patient-centered new drug coverage enhancement. In last month, Lawmaker Lee Yongho convened an online discussion panel on improving patients’ access to new drug amid COVID-19, and Lawmaker Lee Jongseong also led a policy talk spotlighting the neglected health insurance benefit for cancer patients. Both talks shared a common theme of urging to implement the ‘pre-listing reimbursement and post-evaluation’ system to raise the reimbursement rate in all severe disease treatments. Lawmaker Lee Jongseong also proposed a realistic solution to source finance for coverage on expensive anticancer treatment by establishing a ‘cancer control fund.’ The lawmaker has already submitted a partial revision bill on the Cancer Control Act with the said notion. The independent lawmaker demanded Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital to be summoned to the NHIS-HIRA audit session as a representative expert in immunotherapy. The lawmaker plans to publicly raise concern about the anticancer treatment coverage by questioning about new drug approval and catastrophic medical expense. Lawmaker Lee said, “This is the time to put our wisdom together in enhancing the access to new drug centering the people’s rights to health and making the news of new drug development a hope for the patients and their families.” “As a member of the Health and Welfare Committee, I would strive to reinforce the country’s medical system,” he added. Regardless, MOHW has also already expressed an opposing stance on the pre-listing reimbursement for expensive anticancer treatments For the extended questions by Lawmaker Lee Jongseog, MOHW official answered, The pre-listing reimbursement would make drug pricing adjustment difficult when the company refuses to accept the evaluation result, and it could also weaken the National Health Insurance Service’ (NHIS) negotiation power,” so “The issue needs to be reviewed thoroughly as we foresee the difficulties in practical system operation and reasonable pharmaceutical expense management.”
- Policy
- MFDS evaluates documents for prolonged COVID-19 crisis
- by Lee, Tak-Sun Oct 21, 2020 06:32am
- The MFDS decided to skip the pre-GMP survey of imported drugs due to the prolonged COVID-19, and to evaluate the documents without exception. The MFDS postponed the survey after the massive outbreak of COVID-19 in February, and document evaluation was conducted for some items without the survey. However, as COVID-19 situation is prolonged, it is a policy to evaluate documents except when the factual survey should be omitted. The pharmaceutical industry is concerned that it is difficult to replace some items with documents without factual survey. According to the industry on the 19th, The MFDS recently prepared and implemented a pre-GMP evaluation plan for such imported drugs. The MFDS has temporarily prepared an evaluation plan when COVID-19 occurred in February of this year. It was decided to omit the factual survey if appropriate by submitting the PIC/s report, the due diligence report by the regulatory authority, and the result of action on the insufficiency of the inspection result. However, for civil complaints that cannot be omitted from the factual survey, the deadline for consultation will be extended until the end of this year, and on-site surveys will be conducted after COVID-19 situation is over. The MFDS, however, is likely to file complaints about the prolonged period of complaint handling due to the accumulation of items that have not been submitted and the prolonged situation due to the prolonged COVID-19. It is a policy to make an enemy or negative decision. This includes DMF complaints. Accordingly, document evaluation is conducted on all items including items not submitted such as PIC/s reports. However, it is a policy to first select the items that need to be subjected to factual surveys as'companies subject to post factual surveys at overseas factories'. In accordance with this full document review process, GMP evaluation essential data (11 types of data, etc.), which are not submitted as a reason for confirmation at the manufacturer factual survey, must also be submitted. Regarding this plan, an official in the pharmaceutical industry said, "If the cases that can be solved only by conducting a factual survey are replaced with documents, it is more difficult." Another official also said, "There are imported drugs that can be replaced with documents, and we are concerned that these items will become non-conformance cases." However, he explained, "If the MFDS only evaluates the documents, the burden on the pharmaceutical industry will be reduced."
- Opinion
- [Reporter's View] Generic substitution is necessary
- by Lee, Hye-Kyung Oct 21, 2020 06:32am
- The activation of generic substitution was a daily issue at the National Assembly Health and Welfare Committee's national audit held on the 7th to 8th and 13th. It has been a long time since 2015 that the National Assembly has been interested in revitalizing alternative preparations as much as this year. This is also the reason why Young-Seok Seo, a member of Democratic Party of Korea initiated the 'Pharmaceutical Affairs Law Amendment Bill', which allows post-notification to the prescriber or the HIRA after generic substitution. According to the announcement of The MFDS, Pharmacists can make a generic substitution with an item recognized as bioequivalence by the MFDS or a bioequivalence reference drug which is cheaper than the drug prescribed by a doctor. At this time, a 'generic substitution incentive for low-priced drugs' system is also being implemented for pharmacists to receive 30% of the difference in drug price as usage incentives. However, the average of the generic substitution ratio for the five years from 2016 to August 2020 was 0.26%, of which more than 2.3 billion claims were made, in 603 million cases. This means that although the government has implemented an incentive system for the activation of generic substitution, the policy was not effective in the field. Over the past five years, it has saved ₩6,645 million by generic substitution. Excluding the incentives paid to pharmacists, it saved more than ₩4.6 billion in health insurance finances. As the drug cost increased every year, last year, ₩19,321.1 billion was spent as drug cost. The activation of generic substitution can capture some of the drug costs in health insurance medical bills. However, while pointing out the efficacy and side effects of the generic and original bioequivalence tests, doctors are opposed to the generic substitution. It's an old argument. The MFDS is promoting that generics can be taken with confidence because they are the same active ingredients as the original, Minister of Welfare Park Neung-hoo said, "There is no problem with the use of drugs from the patient's point of view as generic substitution is the preparation of drugs that have proven bioequivalence. Efforts are needed so that the people can trust in alternative drugs." The National Assembly proposed an amendment to the Pharmaceutical Affairs Act, and the Review Board said that the DUR system could be used to simplify the generic substitution process. The MOHW also expressed a willingness to improve the replacement dispensing post notification system. The government should create a forum for consultation with medical and pharmacists, and to build public trust in order to trust and take generics.
- Policy
- The intervention in COVID-19 patents should be cautious
- by Lee, Jeong-Hwan Oct 20, 2020 09:16am
- The MOHW said that the government's intervention in a patent related to a vaccine and treatment for COVID-19 developed with public funds from the government should be carefully reviewed. Requesting nation share in patent rights or property rights of private companies just because vaccines and treatments were developed with government funding is the purpose of reviewing various legal grounds and social situations. On the 15th, the MOHW made this announcement in a written inquiry for Seo Young-seok, a member of Democratic Party of Korea. He asked the necessity of national intervention related to patents for COVID-19 vaccines and treatments with public funds. Accordingly, the MOHW said that government-sponsored R&D requires a balance between incentives to achieve performance and publicity. Specifically, the MOHW explained that the R&D performance technology license is granted to the host research institute, but it is collecting technology fees according to the proportion of the government-supported budget, and that the development of COVID-19 vaccines and treatments is applied equally. It means that the results, such as sales profits of COVID-19 vaccines and treatments developed by investing public funds, will be given to pharmaceutical companies, but will collect royalties according to the amount of budget input. The government's administrative basis is the Framework Act on Science and Technology and the Medical Service Technology Promotion Act. However, the MOHW affirmed that the participating pharmaceutical companies expressed their intention to consider national health, such as showing a willingness to provide them free of charge upon successful development. In fact, GC Pharma declared a free supply when it completed the development of plasma therapy in May, and Celltrion said it would not pursue profits with COVID-19 treatment in July. SK Chemicals is also supplying Alvesco, an asthma treatment drug, to 11 hospitals for free. In particular, the MOHW said that the Korean Intellectual Property Office is the supervisory authority for the issue of state intervention in patent rights, and that careful review is necessary. He also inquired about the need to prepare for the invocation of a compulsory license in case the supply of COVID-19 vaccines and treatments is not smooth or it is difficult to secure supplies due to high price. The MOHW said that the necessity of securing vaccines/treatments and initiation of compulsory licenses should be carefully reviewed. Organizations such as the WHO recognize COVID-19 vaccines and treatments as public goods, and the importance of international cooperation in development and distribution is emphasized, and the invocation of a compulsory license should not be decided prematurely. The MOHW said, "The technology license for R&D outcomes is given to the host company, but the provisions of the law to collect technology fees according to the support budget will also apply to COVID-19 vaccine and treatment system." Also it said that the Korean Intellectual Property Office should judge the intervention of the patent right through the law amendment, and a careful review is necessary. The MOHW said that since COVID-19 vaccines and treatments are public goods, international cooperation is important for development and dissemination, and the invocation of compulsory licenses such as manuals should be cautious. In addition, the MOHW added that the two-track strategy will be devoted to the introduction of overseas vaccines in Korea and the rapid development of domestic vaccines.
- Policy
- Government unconvinced of pre-listing reimbursement
- by Kim, Jung-Ju Oct 20, 2020 09:16am
- The South Korean government has technically expressed its opposing stance at a National Assembly audit session questioning about the necessity of adopting the ‘pre-listing reimbursement and post-evaluation system’ that exempts a deliberation on reimbursement feasibility to enhance a severe-case patient’s treatment access. Considering the drug coverage enhancement process has been fast regardless of new drugs’ pricing surging, the government views focusing on listing speed would rather risk the pricing management or post-management, which could lead to worsening financial management. The Ministry of Health and Welfare (MOHW) submitted a statement with the said answer for the National Assembly Health and Welfare Committee audit. The written answer is an extension to the MOHW National Assembly audit convened for two days on Oct. 7 and 8. According to the material MOHW provided to Lawmaker Jeon Bongmin, the government is still in process of enhancing the National Health Insurance (NHI) coverage centering cancer and severe disease treatments. Compared to 2016, the government has spent 25 percent more on pharmaceutical expense in 2019. And the expense spent on anticancer treatment during the same time almost doubled to 59 percent. The overall pharmaceutical expense has surged from 15.4 trillion won in 2016 to 19.3 trillion won in 2019. From August 2017 to the base year, total 58 items have been listed and the expense was increased by 1.6 trillion won originally from 1 trillion won. Some argue the ‘pre-listing reimbursement and post-evaluation system’ should be introduced to limited subject to improve the treatment access even further. Regarding the issue, Lawmaker Lee Jongseong questioned the ministry if the pre-listing reimbursement and post-evaluation system is needed as an alternative listing system for severe and rare disease treatments. But in the end, MOHW rejected the suggestion. MOHW official said, “The pre-listing reimbursement would make drug pricing adjustment difficult when the company refuses to accept the evaluation result, and it could also weaken the National Health Insurance Service’ (NHIS) negotiation power,” so “The issue needs to be reviewed thoroughly as we foresee the difficulties in practical system operation and reasonable pharmaceutical expense management.” However, the ministry added other regulations and systems currently in effect are contributing in the enhancement of the treatment access. MOHW official answered, “The Ministry of Food and Drug Safety (MFDS) has been operating the ‘approval-evaluation linkage system’ that conducts a reimbursement feasibility evaluation on rare disease treatment prior to their approval. And also the ministry is actively seeking means to shorten the overall listing review duration with pharmacoeconomic evaluation exemption system and shortened drug pricing negotiation.”
- Policy
- Improvement of reimbursement standards for Prolia is needed
- by Lee, Hye-Kyung Oct 20, 2020 09:15am
- The government has announced that it will comprehensively review the reimbursement standards for osteoporosis treatments such as 'Prolia (Denosumab)'. The MOHW expanded Prolia, which was used as a second-line treatment for osteoporosis last year, as a first-line treatment, and recognized reimbursement even if continuous administration is necessary. However, Bong-min Jeon, a member of People Power Party, pointed out that the governement should actively take steps from checking for osteoporosis to creating a continuous treatment environment and establishing an integrated treatment system for preventing fractures in stages at the National Assembly Health and Welfare Committee's national audit held on the 7th. The MOHW replied, "We will comprehensively consider and review the principles of insurance reimbursement, such as clinical usefulness, cost effectiveness, and financial requirements," in relation to the improvement of the osteoporosis treatment reimbursement standards that he argued through a written questionnaire on the 15th. Currently, osteoporosis treatment is based on the Pharmaceutical Reimbursement Listing Standard and Method’s General Principles and drug-specific reimbursement standards, and when measuring bone density, within 3 years of confirmation of osteoporotic fracture, and within 1 year of bone density measurement T-score below -2.5 Reimbursement is recognized for 1 year. The MOHW said that the standards were continuously expanded by referring to textbooks, guidelines, and academic opinions. It explained that the duration of administration of the osteoporosis treatment is set differently according to the measurement of bone density and the presence of osteoporotic fractures, and that patients with low bone density measurements through follow-up tests are continuously administered regardless of the duration.
- Company
- Submission of α-GPC clinical reevaluation plan is imminent
- by Chon, Seung-Hyun Oct 20, 2020 06:35am
- Pharmaceutical companies are preparing in earnest with two months ahead of the deadline for submitting data for the clinical reevaluation plan of Choline alfoscerate. They are contemplating the indications for clinical trials and clinical work. The method of paying the cost of clinical trials and the process of selecting participating companies will not be easy. According to industry sources on the 19th, the MFDS announced in June that it would conduct a clinical reevaluation of Choline alfoscerate. The MFDS requested that 134 companies submit the results of domestic clinical trials for 255 items. In case of conducting a clinical trial, it was instructed to submit a clinical trial protocol by December 23rd. Accordingly, companies that hold Choline alfoscerate are busy preparing clinical trial plans. According to the existing clinical re-evaluation practice, it is highly likely that companies with large sales will take the lead in conducting clinical trials and other companies will participate in a way that shares the cost. Companies such as Chong Kun Dang and Daewoong Bio have started to set up a full-fledged clinical trial plan. It is said that these companies will soon meet with the MFDS representative to discuss clinical trial design, etc. Choline alfoscerate is a drug that has three indications: ▲Secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral temperamental syndrome ▲Emotional and behavioral changes, and ▲senile pseudodepression. In principle, clinical trials for each indication should be conducted and data proving efficacy should be submitted. However, pharmaceutical companies are also considering how to set targets and conduct clinical trials by slightly changing existing indications. The MOHW acknowledged that it is effective against 'secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal syndrome' of patients diagnosed with dementia, and determined the positive list system for patients diagnosed with dementia and other patients. The method of separating and conducting clinical trials was also being considered. A method of separately conducting clinical trials by dividing the indication area for each pharmaceutical company could also be promoted. Another brain function improvement agent 'Acetyl-L-Carnitine' was also divided by company and clinical reevaluation was conducted. Acetyl-L-Carnitine, generic for Dong-A ST's Nicetile, has been approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular disease'. When The MFDS ordered a clinical re-evaluation in 2013, Dong-A ST took the lead in conducting a “primary degenerative disease” clinical trial. Hanmi was in charge of the clinical trial for "secondary degenerative diseases caused by cerebrovascular disease." In July last year, Acetyl-L-Carnitine was removed from the indication for a “primary a degenerative disease” because the clinical results conducted by Dong-A ST did not meet the efficacy. Hanmi is still undergoing clinical trials. When the clinical trial design and clinical method of Choline alfoscerate are determined, the recruitment process for participating companies is expected to proceed. At this time, it is also an issue of how each company will bear the cost of clinical trials. If each company decides to pay the same clinical cost, companies with small sales volume of Choline alfoscerate will have to consider participating in reevaluation. If the submission of clinical reevaluation data is abandoned, the authorization will be revoked. The risk of redemption due to the price-volume agreement is also a burden for pharmaceutical companies. Recently, some pharmaceutical companies with Choline alfoscerate agreed to adjust drug prices according to the price-volume agreement negotiation system. The agreement stipulated that when a clinical trial is conducted for the renewal of the MFDS's product license and re-evaluation of drugs, the relevant facts should be notified to the NHIS. If the approval is withdrawn as a result of reevaluation, etc., the pharmaceutical company has a clause that requires the NHIS to return the full amount of the bill from the date the MFDS makes the clinical trial to the date of the removal of the list. If a pharmaceutical company has agreed to reduce the drug price of Choline alfoscerate according to the price-volume agreement negotiation system, and withdrawal from the market as a result of a re-evaluation later, all sales sold so far must be returned to the NHIS. If pharmaceutical companies fail to demonstrate the efficacy of Choline alfoscerate in clinical trials, approval may be revoked in the worst case. At this time, for products that have undergone the price-volume agreement negotiation system, all prescription amounts must be returned from negotiation to cancellation of the license. For example, if Choline alfoscerate with an annual prescription amount of ₩10 billion is canceled due to a clinical trial failure 5 years after the price-volume agreement negotiation system, ₩50 billion will be required. Drug price agreement based on the Price-Volume agreement Pharmaceutical companies are inevitably burdened with clinical reevaluation. An industry official said that there are a lot of homework from setting up clinical design to recruiting participating companies with about two months left until the submission of the clinical reevaluation plan. He said, "With the burden of uncertainty about the revaluation results, a lot of pain between pharmaceutical companies is inevitable."
