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- 2026-04-13 14:48:09
- Policy
- The benefit of 7 α-GPC products will be suspended
- by Lee, Hye-Kyung Oct 19, 2021 08:53pm
- Benefits for seven items that have been canceled for not participating in the clinical re-evaluation of the brain function improvement drug Choline alfoscerate will be suspended from the 21st. The MOHW announced on the 18th that it has decided to suspend health insurance benefits for drugs that have been canceled for product licenses due to confirmation of violations of the Pharmaceutical Affairs Act. The seven items violating the Pharmaceutical Affairs Act were canceled following the first two-month suspension of sales and the second six-month suspension of sales without complying with Article 33 (Regulations on the Reevaluation of Drugs) under the Choline alfoscerate formulation. The head of the MFDS may reevaluate drugs that need to be reviewed for safety and effectiveness, or that need to prove drug equivalence among drugs that have been approved or reported. In June of last year, the MFDS announced in June last year that it would conduct a clinical re-evaluation of three indications like ▲ secondary symptoms and denaturation or degenerative cerebral matrix mental syndrome caused by cerebrovascular defects, ▲ changes in emotions and behaviors, including ▲ senile pseudophobia. The MFDS ordered 255 items from 134 companies to submit clinical trial plans by December 23 of that year. More than 60 pharmaceutical companies participated in the clinical re-evaluation of Choline alfoscerate, divided into Daewoong Bio-Chong Kun Dang Group and United Group, while the rest of the pharmaceutical companies are receiving administrative measures such as suspension of work and cancellation of item without submitting clinical plans. Samik's Memoode, KMS Pharm's Alfotne Soft Cap, Austin Pharm's 'Newcholine Soft Cap', Intropharm's I-Choline, Saehanpharm's Glatone, and Mirae Pharm's Gliarin will be suspended. Medical institutions such as hospitals, clinics, and pharmacies should note that they cannot prescribe and prepare benefits from the 21st as seven items will be removed from the list due to the cancellation of item licenses.
- Company
- Hugel’s Geodu BTX plant completes EMA inspection
- by Lee, Seok-Jun Oct 19, 2021 06:00am
- [Hugel announced that the European Medicines Agency completed the on-site inspection of its ‘Geodu plant’ in Chuncheon on the 18th. The Geodu plant has a fully automated state-of-the-art system that can manufacture over five million botulinum toxin vials a year. EMA conducted an on-site inspection on the Geodu plant’s manufacturing facilities and quality control system for 3 days, from the 12th to the 14th, to verify whether the facility complies with the EU-GMP standards. With the on-site inspection complete, the company expects to acquire the EU GMP certification soon. The company had previously completed FDA’s on-site inspection for cGMP in August. A Hugel official said, “ With the recent inspection of EMA’s Geodu plant complete, the company expects to be able to soon emerge into the European market in addition to its entry into the Chinese market last year. By entering the European market this year, and the US market next year, we aim to continue our endeavors to become a global company that covers 95% of the world’s botulinum toxin market. The European market, combined with the US market accounts for 70% of the world’s botulinum toxin market. With the aim to emerge into the European market, Hugel completed its Phase III clinical trials(Bless 1 and Bless 2) in Poland and Germany with an Austrian medical aesthetics pharma company ‘Croma,’ and submitted an application for marketing authorization in June 2020.
- Policy
- Korea United Pharm's Galvusmet generic is the first approved
- by Lee, Tak-Sun Oct 19, 2021 06:00am
- Korea United Pharm received approval for the first generic of Novartis’s DPP-4 inhibitor, ‘Galvusmet (vildagliptin/metformin hydrochloride),’ an antidiabetic treatment. With the approval, the company will likely be competing with Hanmi Pharmaceutical next year, which marked the start of Galvusmet latecomers with a salt-modified drug in July. The Ministry of Food and Drug Safety approved Korea United Pharm’s Galvusmet generic on the 18th. The product is a fixed-dose combination of vildagliptin and metformin hydrochloride and is a generic drug that contains the same ingredient as Novartis’s Galvusmet that was approved in 2008. The drug was approved as an adjunct to diet and exercise to improve glycaemic control in type 2 diabetes patients that are eligible to take the vildagliptin+metformin combination. With the substance patent for the single-agent drug Galvus and combo Galvusmet to expire on March 4th of next year, companies of latecomer drugs are accelerating development to preoccupy the patent-expired market. Twelve companies including Ahn-Gook Pharmaceutical, Ahngook New Pharm, Hanmi Pharmaceutical, Genuone Sciences, LitePharmTech, White Life Science, PharmGen Science, Mother’s Pharmaceutical, Daewoong Bio, Dongkoo Bio&Pharma, KyungBo Pharm, GL Pharma have already received approval for latecomer single-agent vildagliptin products. Among the companies, Ahn-Gook Pharmaceutical and Ahngook New Pharm succeeded in avoiding the original's patent by challenging part of the term extended for the substance patent of Galvus and achieved generic exclusivity from January 9th to May 29th. Therefore, other drugs with the same vildagliptin ingredient as those approved by Ahn-Gook Pharmaceutical and Ahngook New Pharm cannot be sold during the term. However, drugs with a different salt ingredient are not considered identical and are not subject to sales restrictions. Also, the vildagliptin/metformin combination agents are also not subject to sales restrictions under Ahn-Gook’s generic exclusivity. Until now, only Hanmi Pharmaceuticals and Korea United Pharm received approval for a latecomer combination drug. However, Hanmi Pharmaceuticals’ product is a salt-modified drug and not a generic of the same ingredient. Hanmi and United succeeded in avoiding the composition patent of Galvusmet through a passive trial to confirm the scope of rights and may start the sale of their products after the original’s product patent expires. In other words, the companies may sell their products without any issue from March 4th. In addition, if the companies receive a ruling confirming the ruling made by the Patent Court of Korea in the trial to invalidate the extended period of substance patent that is pending in the Supreme Court, the companies may be able to sell their drugs from January of the next year. The trial is currently ongoing between Novartis, the patent holder, and the latecomer companies, Ahn-Gook Pharmaceutical and Hanmi Pharmaceutical. As Hanmi and United had received approvals of their respective drugs before October, they may even be able to release their products with insurance benefit in January. Therefore, the two companies are expected to compete fiercely to preoccupy the market. By market size, the Galvusmet has a much larger market than the single-agent Galvus. According to UBIST, outpatient prescription sales of the drugs last year was ₩8.1. billion for Galvus and four times higher - ₩36.4 billion - for Galvusmet. With rapid commercialization being the key to preoccupying this immense Galvusmet latecomer market, Hanmi and Korea United Pharm seem to have taken a lead.
- Company
- Hugel's Letybo benefits from FDA delay of Revance's DAXI
- by Nho, Byung Chul Oct 18, 2021 05:54am
- The U.S. Food and Drug Administration’s disclosure of the official document outlining concerns in the DAXI manufacturing plant of the botulinum toxin company, Revance Therapeutics (hereinafter ‘Revance’), raised industry concerns about the uncertainty of the company’s approval. Revance is a new medical aesthetics company that sells botulinum toxin and HA filler products. The company had submitted a Biologic License Application to the FDA for its botulinum toxin product DAXI in 2020 and expected to receive marketing authorization by 2021. The FDA conducted an on-site inspection of the company's manufacturing plant from late June to early July. The document that was disclosed this time had pointed to 4 issues of concern, which includes the issues that the actual manufacturing process is not the same as in the application for the marketing authorization, and the verification of the Working Cell Bank is inadequate. Upon disclosure of such concerns, Revance announced that it still expects to receive approval within the year. However, the industry expects that it would take considerable time before the company can make up for the serious issues discussed by the FDA. Currently, Allergan’s Botox accounts for 75% of the 2 trillion dollar botulinum toxin market, virtually dominating the market. The US market, therefore, has a high need for a new company that has a premium botulinum toxin product with a reasonable price. Companies that have recently submitted a marketing approval to the FDA for their botulinum toxin and underwent review include the US company Revance and Korean company Hugel. An industry official said, “Expectations for Hugel’s entry in the US market is increasing as the competition between the new companies, Revance and Hugel, has fallen apart with the FDA’s document that rendered the date of Revance’s marketing approval uncertain. Hugel has smoothly completed its on-site inspection and mid-cycle meeting. The official added, “Hugel completed submission of the supplementary material requested by the FDA after its inspection and is expected to pass review without issue." The FDA had conducted a cGMP inspection for nine days from August 12-20 to verify the manufacturing facilities and the quality management system of Hugel’s second plant that is in charge of the production of Letybo.
- Company
- Novartis applies for another gene therapy, Luxturna
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- Novartis has applied for the registration of insurance benefits for another new one-shot gene therapy drug. According to related industries, Novartis Korea recently submitted an application for benefits for the Inherited Retinal Dystrophy (IRD) treatment "Luxturna (Voregenene Neparvovec). Luxturna restores its function by replacing the deficiency and defective RPE65 gene, one of the causes of IRD, with a normal gene with just one administration. In other words, fundamental treatment of diseases is possible. The drug was designated by the U.S. FDA as a target for Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained rapid approval in 2017. IRD is a rare refractory disease that causes visual loss due to mutations in genes responsible for retinal optic cell structures and functions. It contains more than 20 various eye diseases and has about 300 causative genes. IRD, caused by RPE65 gene mutation, causes abnormalities in the visual cycle in the retina that converts visual information into neural signals and transmits it to the brain. The RPE65 gene mutation can reduce the RPE65 protein essential for visual circuits and gradually narrow the field of view as retinal cells are destroyed, which can eventually lead to blindness. Kang Se-woong, chairman of The Korean Retina Society (Professor of Ophthalmology at Samsung Medical Center), said, "Luxturna can expect recovery to the extent that independent walking is possible without the help of a guardian with a single injection." Luxturna proved its effectiveness through phase 3 clinical trials conducted in patients with hereditary retinal disease whose double confrontational trait mutation of the RPE65 gene was confirmed. Clinical results show that the patient group who received Luxurna treatment at 1 year of treatment had statistically functional vision than the control group who did not receive treatment. It has improved significantly. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT) at the time of 1 year of treatment as a primary evaluation variable, the score change of the Luxturna treatment group was 1.8 points, 1.6 points higher than the control group's score change of 0.2 points. In the darkest 1lux (Lux), 65% (n=13/20) of the Luxturna treatment group reported the maximum improvement in MLMT scores, while none of the controls passed.
- Policy
- Keytruda·Tagrisso is in the process of expanding benefits
- by Lee, Hye-Kyung Oct 18, 2021 05:54am
- There was an opinion calling for expediting the expansion of the benefit standard for tumor-agnostic therapy. Independent lawmaker Lee Yong-ho said in a parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, "Benefits of Keytruda & Tagrisso have not expanded and are causing pain to patients," adding, "Keytruda's first lung cancer benefit has not been expanded for four years. I think many patients would have lived during that period." Han Hyun-ho, a clinical assistant professor at Yonsei University's urology department, who attended as a reference at the request of lawmaker Lee, demanded the urology benefit of Keytruda. Professor Han said, "Keytruda is an anticancer drug approved for tumor-agnostic therapy overseas," adding, "It can be used in patients with bladder cancer and prostate cancer in urology." In response to such criticism, Kim Sun-min, director of the HIRA said, "Keytruda is expensive and takes a lot of finance," adding, "We are also considering the cost-effectiveness of clinical sites." Director Kim said, "The HIRA is also being reviewed, and the term-agnostic therapy has set benefit standards and is in the process of follow-up procedures," adding, "We will quickly strengthen the coverage of cancer patients." However, he added that kidney cancer and bladder cancer have not yet received clear evidence based on the HIRA, so review will be conducted after clinical research is conducted.
- Policy
- “Impartiality of reimbursement review system undermined"
- by Lee, Jeong-Hwan Oct 18, 2021 05:54am
- HIRA president Sun-Min Kim (left) is answering to People Power Party member Jung-sook Suh’s inquiry (Pic provided by National Assembly Press Corps)The principal investigator of the clinical trial of lung cancer drug B participated in lung cancer A drug’s reimbursement assessment meeting. Isn’t this a conflict of interest and cause for the member’s exclusion from the committee?” (People Power Party Jung-sook Suh) “There are operational regulations set for the Cancer Disease Deliberation Committee, however, it is difficult to regulate the members’ participation in competitor drug’s clinical trials” (HIRA president Sun-Min Kim) Controversy over the fairness and expertise of the Health Insurance Review and Assessment Service and its Cancer Disease Deliberation Committee has risen in the course of providing health insurance benefits for non-small cell lung cancer treatments. The issue was that a professor of a medical school who is in charge of the clinical trial of lung cancer drug B, a competitor drug, had participated in the reimbursement review of the lung cancer drug A, which is a conflict of interest that undermines the impartiality of HIRA and the expertise of CDDC. On the criticism, HIRA’s president Sun-Min Kim expressed the service’s position that it would be difficult to exclude all professors who participated in clinical trials of competitors' drugs from the reimbursement reviews. NA member Jung-sook Suh of the People Power Party had inquired so to HIRA president Sun-Min Kim at the NHIS·HIRA’s NA audit on the 15th. Suh had pointed out that it is inappropriate for the principal investigator of a competing company to participate in the drug reimbursement review of its competitor drug. Suh's point of view was affected by the appeal made by a lung cancer patient group that visited the National Assembly to ask for the extended reimbursement of the lung cancer drug A. With lung cancer drug A failing to receive reimbursement for several years, some have been criticizing that this was an infringement of the patients’ right to accessibility. Currently, the lung cancer drug A has been approved for reimbursement as a second-line treatment and applied to extend its reimbursement to first-line. The competitor drug B is currently conducting clinical trials to assess its efficacy in the first line. Suh said that professor K, principal investigator of the clinical trial of lung cancer drug B, participating in lung cancer drug A’s reimbursement review raises the issue of fairness. The professor had participated in the Cancer Disease Deliberation Committee meeting in April that reviewed the reimbursement of lung cancer drug A as first line. Suh used the committee’s exclusion, recusal, and avoidance regulations to point out that the situation has greatly undermined the objectivity of the reimbursement review for lung cancer drug A. According to Article 13-2 of the Operating Regulations of the Cancer Disease Deliberation Committee, if a person who attends the committee and makes a statement is deemed not to be fair or objective due to family relations or personal and economic interest under the civil law, the committee shall refuse the participation and statement of the committee member. Seo said, “It is very inappropriate for the principal investigator of the competitor lung cancer drug B’s clinical trial, professor K, to participate and deliberate on lung cancer drug A’s first-line reimbursement. According to the Operating Regulations of the Cancer Disease Deliberation Committee, professor K should have refused to participate or provide an opinion on the matter. A serious and clear flaw in the committee’s operations have been revealed, and HIRA should explain why this has happened and come up with measures to prevent recurrence “ While expressing some agreement to Suh’s argument, HIRA president Sun-min Kim expressed the service’s position that it would be difficult to regulate the member’s participation in other drugs’ clinical trials as exclusion criteria in the operating regulations. Kim said, “Operating Regulations for the Cancer Disease Deliberation Committee does exist, however, it is difficult to regulate the members’ participation in competitor drug’s clinical trials.”
- Policy
- Introduction of CDF for Zolgensma was proposed
- by Lee, Hye-Kyung Oct 18, 2021 05:54am
- When the National Assembly proposed the introduction of the Cancer Drugs Fund (CDF) for Zolgensma, the NHIS accepted the beginning of the discussion. Rep. Kim Sung-joo of the Democratic Party of Korea said in a parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, "There was a story of a new drug worth 2.5 billion won per time, but patients are losing valuable time because of pharmaceutical companies and the government trying to cut drug prices." "An alternative approach is needed to this issue," he said. Rep. Kim said, "I think a new fund is needed if there is no agreement between the parties." He said, "I want to propose an anticancer drug fund like the UK. I also know that a bill has been proposed for pharmaceutical companies, the government, and private foundations to pay for treatments that have been proven cost-effective in health insurance. "I want to ask what the chairman thinks," he asked. In this regard, Chairman Kim Yong-ik said, "CDF seems to be an important proposal," adding, "As of now, there is no discussion, so there is nothing good or bad about it." "I will say that we should open the beginning of the discussion," he said.
- Company
- Bayer·Viatris·Pfizer settles in new locations
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- News of multinational pharmaceutical companies’ relocations continue. According to industry sources, Korean subsidiaries of multinational pharmaceutical companies including Bayer, Viatris, and Pfizer have decided on their new offices and are working on relocation projects. Bayer Korea, which had been located in Boramae, Dongjak-Ku for a long period of time, will move to Yeouido next month (in November). Bayer’s new company building will be located in Yeoido’s hot place, Parc1 Tower. With the relocation, the company’s new headquarters will become a smart office with improved transport access, which was one of the disadvantages of the existing office building. Yeoido has risen as a strategic core in the pharmaceutical industry since 2018 when Novartis Korea has moved into the IFC building. With Bayer’s relocation, a total of 4 pharmaceutical companies – Bayer Korea, Biogen Korea, Alvogen Korea, and Novartis Korea – will be in Yeoido. Viatris Korea, a spinoff of Pfizer Korea, has confirmed its relocation to the Grand Central Tower near the Seoul Station earlier next year. Viatris had been using the shared office ‘FAST FIVE Myeong-dong’ as a temporary office from August until the end of this year. Viatris plans to actively reflect the various experiences it accumulated in the shared office to establish a smart working environment in the new headquarters so that employees can work at ease. At FAST FIVE Myeong-dong, employees were able to choose from the open space where they can perform individual tasks, one-person independent space for virtual meetings, and meeting space for 2-3 to 10 or more people, to meet the employee’s individual needs. After selling Myeongdong’s landmark Pfizer Tower at ₩112 billion, Pfizer opted to maintain its geographic legacy. The company sold its building to GRE Partners 15 months after the building was put on sale. After discussing various options, the company had decided on Namsan State Tower as its new home and plans to move in next year. The new office is located within a walking distance of the existing Pfizer Tower and will be moving into the new building in the second half of next year. Meanwhile, new Korean subsidies of multinational pharmaceutical companies are being established this year. The promising Chinese pharmaceutical company ‘BeiGene’ established a new subsidiary in Korea, and Moderna, one of the COVID-19 vaccine developers, has also registered its corporation and is awaiting launch in Korea.
- Policy
- The HIRA also decided to disclose the results of Kymriah
- by Lee, Hye-Kyung Oct 15, 2021 05:58am
- The HIRA has decided to disclose the results of the drug benefit assessment. Although the entire evaluation process required by citizens, patient organizations, and the pharmaceutical industry is not disclosed in detail, it has decided to clearly disclose the establishment of benefit standards and appropriateness of benefits. The HIRA released the "7th Severe Cancer Drugs Benefit Appraisal Committee's deliberation results" at 6:23 p.m. on the 13th, and distributed a press reference to Kymriah deliberated at the Cancer Drugs Benefit Appraisal Committee at 10:46 p.m. The results of the Cancer Drugs Benefit Appraisal Committee deliberation include the items applied for the medical care benefit decision, pharmaceutical companies, efficacy and effect, deliberation results and expanded benefit standards. It is similar to the scope of disclosure of the results of the Drug Reimbursement Evaluation Committee review, which has been released since June 2017. Following the Drug Reimbursement Evaluation Committee, the HIRA decided to distribute the results of the Cancer Drugs Benefit Appraisal Committee deliberation on the media and website in the form of press references after the end of each month's meeting. Kim Ae-ryeon, head of the drug management office, said, "There have been demands for disclosure of the results of the Severe Cancer Drugs Benefit Appraisal Committee, and some unwanted pharmaceutical companies have been curious about expensive drugs and discussed with the Cancer Drugs Benefit Appraisal Committee." Regarding the press reference related to Kymriah, she said, "In addition to setting the benefit standard, Kymriah's reference data were exceptionally released." She said, "It was also dealt with in this parliamentary audit, and there were several issues. It won't come out continuously." The HIRA is considering the timing of distribution of press reference materials. Like the Drug Reimbursement Evaluation Committee, it was also scheduled to distribute press references the morning after the meeting. However, due to the issue drugs such as Kymriah, it announced that it would be distributed after 6 p.m. on the 13th, shortly after the end of the meeting, and distributed to reporters immediately after the monthly meeting. In this regard, Director Kim said, "We will need to consider the timing of distributing the press reference materials of the Drug Reimbursement Evaluation Committee and the Cancer Drugs Benefit Appraisal Committee," and added, "We will review the timing after the parliamentary audit and finalize it."
