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- 2025-12-24 13:21:12
- Policy
- 18 Champix IMD suspected of selling before patent expiration
- by Lee, Tak-Sun Jun 15, 2020 06:16am
- Pfizer 18 incrementally modified drugs (IMDs) of Champix (varenicline) are undergoing administrative measure for selling the products before the original’s patent was expired. Some of their item approvals have been revoked by the related administrative measure. Before the Champix’ patent expires next month, the follow-on drug market would fluctuate depending on the administrative measures. Korea’s Ministry of Food and Drug Safety (MFDS) announced on June 11, the ministry’s regional offices are reviewing 18 IMDs (nine 0.5 mg products and nine 1 mg products), which have been accused of going on sale before the original extended the patent term. The licenses on Korea Prime Pharm’s Champion in 0.5 mg and 1 mg tablets have been revoked by related statutes. Administrative measures on other items would be finalized when the regional offices complete respective reviews. Apparently, these items are suspected of going on sale before Champix extended the patent, although they stated the sale would be withheld until the expiration date as they were approved by the health authority. Champix’ substance patent expiration date before extension was on Nov. 11, 2018. And extended term would expire on July 19, 2020. Based on the Korean court’s ruling, most of the IMDs have gone sale from Nov. 14, 2018, when the original’s patent expired. But when the Supreme Court overruled the preceding decision and disapproved of IMDs evading patent infringement during the extended patent term, all IMDs have ceased manufacturing and sales. Instead, they are to resume the sale starting from July 19, when the extended patent term expires. The items receiving the administrative measure were supposed to resume the sale from next month. But, the sales plan could be scrapped as they are suspected of selling the products before the patent expiration. Relevant pharmaceutical companies would be affected as the item approval on an IMD selling before the patent expiration is immediately revoked, according to the highest level of administrative measure.
- Policy
- The packaging unit of self-injectable medicine is improved
- by Lee, Tak-Sun Jun 15, 2020 06:15am
- The packaging unit of self-administered injections such as Saxenda, which is used for appetite suppression, is expected to be subdivided. In order to prevent misuse, it was decided to put one in one package. In addition, safety information is produced for patients to use it correctly, and educational program development and medication guidelines are prepared. The MFDS announced on the 11th that it is pursuing a comprehensive measure to support the safe use of self-administered injections, which the patients themselves directly inject. It is said that this measure was prepared to strengthen the safe use and to eliminate medicine’s abuse as the product launch and use expanded due to the convenience of self-administered injection. First, the safety use information that the patient participates in is produced. The intention is to construct a patient panel for self-administered injections to produce safety use information that reflects consumer opinions from the planning stage to delivery and provision. In addition, the existing promotional materials will be reviewed. Patient education programs are also established through consultation with groups of doctors or pharmacists. The doctors' association decided to develop an education program and practice training for patients using self-administered injections. In addition, it was decided to form a consultative body with the pharmaceutical assiociation to prepare a method for strengthening medication guidance for patients and a medication guide. In order to prevent abuse, the product packaging unit is also reduced. The plan is to improve the current packaging unit, which is packed up to five per product, to one. In addition, it was decided to add 'self-administered injection' to the subject of risk management plan submission and to describe in detail how to use it in containers, packaging, and attached inserts The MFDS also plans to promote the use of self-administered injections at home and abroad and research on the current education status. An official from the MFDS said, “We are looking forward to creating an environment where patients can safely use self-administered injections without fear of misuse through this measure. And, we will do our best to continue to communicate with patients, experts, and the industry to expand the foundation for safety commercial use.”
- Policy
- 13 COVID-19 global clinical trials were approved
- by Kim, Jung-Ju Jun 11, 2020 06:53am
- Global clinical trials for the development of COVID-19 vaccines and treatments have increased 15 fold more than in three months. There are 858 cases worldwide and 13 cases approved in Korea, and clinical trials are actively underway. The KONECT (Chairman Byung-Joon Bae) announced on the 9th that it updated the domestic and foreign clinical trial trend information for the development of COVID-19 vaccines and treatments. As of the 8th, there were 858 drug interventional clinical trials that were newly registered in the National Institutes of Health (NIH) ClinicalTrials.gov. The total number of clinical trials increased by 15.3 times from 56 cases to 858 cases as of March 11th. In particular, the number of sponsor-investigator trials increased by 17.7 times from 32 to 565, and it was analyzed that the clinical trials of researchers aimed at the public interest in responding to the national public health crisis are driving clinical research. Of the 858 clinical trials, 825 clinical trials related to treatment and 33 clinical trials related to vaccines. Among clinical trials related to treatment, 546 clinical trials by researchers, 264 clinical trials by pharmaceutical companies, NIH and U.S. Fed-sponsored clinical trials were 15 cases, and the proportion of researchers' clinical studies was 66.2%. Among clinical trials related to treatment, 546 clinical trials by researchers, 264 clinical trials by pharmaceutical companies, NIH and U.S. Fed-sponsored clinical trials were 15 cases, and the proportion of researchers' clinical studies was 66.2%. Korea has 13 clinical trial plans related to COVID-19 approved by the MFDS as of 8th. Of these, 12 clinical trials related to treatment and 1 clinical trial related to vaccines were conducted, and 7 sponsor-investigator trials (53.8%) were reported to be in progress. Meanwhile, information on the current status of clinical trials related to COVID-19 can be viewed and downloaded from the Korean Clinical Trial Portal (K-CLIC).
- Policy
- About 70% of new anticancer drugs are listed
- by Lee, Hye-Kyung Jun 11, 2020 06:22am
- The average listed rate for new drugs approved in Korea was 67.2%. Looking at the rate of chemotherapy drug listed alone, it was 70.2%, which is higher than all new drugs. Korea Institute for Health and Social Affairs This data was shown on the 8th through the 'Health and Welfare ISSUE&FOCUS (Silvia Park, Korea Institute for Pharmaceutical Policy Affairs, Solyip Ha, Social Budget Research Group)' published by the Korea Institute for Health and Social Affairs. As a result of analyzing 570 new drugs approved in Korea from 2007 to 2018 by the Korea Institute for Health and Social Affairs, Trends in new drug properties seen in the global market have recently been observed, such as increased treatment for severe diseases, higher costs, and uncertainty in the basis for decision making. As a result of analyzing the database of the MFDS, the annual average of 47.5 new drugs has been approved over the past 12 years. Of these, 141 new anticancer drugs accounted for 24.7% of all new drugs, and since 2007, the proportion has increased gradually, accounting for about 39% in 2016 and 2017. As a result of comparing the health insurance drug price file and claim data based on the MFDS, as of May 2019, 383 items, 67.2% of the 570 new drugs approved, were listed on the reimbursement list. Anti-cancer drugs, 99 items (70.2%) out of the total 141 items were listed, showing a higher listing rate than all new drugs. Anticancer drugs that were approved in 2013~2015 have a very high guarantee rate of about 90%, and the incidence rate of approved anticancer drugs after 2016 is likely to increase further. Among the new drugs for anticancer drugs, 45.5% of them were listed as risk-sharing agents (RSA). In particular, the ratio of RSA to reimbursement was more than 90% in the case of licensed anticancer drugs from 2016 to 2017, after the policy to strengthen the guarantee in 2014. In the United States or the European Union, the percentage of drugs approved for sale under conditional approval was the highest in RSA-listed new drugs at 66.7%, with 46.8% for anticancer drugs and 15.4% for all new drugs. The expenditure on health insurance drug for new drugs increased from ₩392.5 billion in 2012 to ₩1.89 trillion in 2017, while the expenditure of new drugs for anticancer drugs increased from ₩20 billion in 2012 to ₩209.6 billion in 2017, and the share of new drug costs increased by about four times from 5.1% in 2012 to 19.2% in 2017. Among the new drugs in 2014, the RSA drug cost was ₩20.9 billion, accounting for 2.9% of the total new drug cost, while in 2017, the value rose to ₩76.8 billion and 7.1%, respectively. The cost of RSA in anti-cancer drugs increased rapidly from 3.3% of total anti-cancer drug drugs to ₩2.7 billion in 2014, to ₩75.6 billion in 2017 and 36.1%, respectively. If the new drug listed in 2012 took 97 days to be used for the first time in advanced general hospitals, it was shortened to 28 days in 2017. The percentage of total drug expenditures for new drugs that are less than 6 years old are listed as 3.48% in 2013 from 4.68% in 2017. %. As a new drug for anticancer drugs, the proportion of total drug expenditures for products with less than 6 years of entry into the drug increased from 0.35% in 2013 to 0.91% in 2017, and also increased annually. "The proportion of anticancer drugs in the number of new drugs and the expenditure of new drugs is increasing, and new drugs registered as RSA are increasing," said the Korea Institute for Health and Social Affairs. The institute said, "We need a policy to secure financial continuity by strengthening the clinical efficacy evaluation structure of new drugs in our decision to manage uncertainty in new drugs and secure access to innovative new drugs."
- Policy
- Kolmar begins patent challenge
- by Lee, Tak-Sun Jun 09, 2020 06:28am
- More and more domestic pharmaceutical companies are greedy with generic drugs from Novartis' DPP-4 diabetes treatment drug 'Galvus'. On the 5th, Kolmar Korea filed a passive trial to confirm the scope of a patent right to avoid patents. It has been 7 months since it was approved for bioequivalence test for development of generics in November last year. Normally, patent challenge and commercialization are developed at the same time, but Kolmar entered the patent trial later. This is because Galvus' patent challenge results could not be easily predicted. As such, Kolmar seems to have been following the referee situation requested by the Korea United Pharm and Hanmi as it proceeds with product development. In addition to Kolmar, Hanmi and Korea United Pharm are in the process of patent challenge with the exception of patented indications. The rest of the indications have already expired. In other words, the product they made was claimed by the Intellectual Property Trial and Appeal Board. Hanmi’s Vildagle was already approved as Galvus' salt-modifying product in January, and acquired an insurance price of 403 won per tablet as of April. Korea United Pharm, which was approved for the bioequivalence test in November, has not yet obtained an item license. Hanmi has not yet released a product. The patent trial request has not been made yet. Novartis is currently filing a patent infringement lawsuit against Hanmi, and is pressing the MFDS through a lawsuit for revocation of permission. However, if the claims are cited in the patent trial expected this month, the product will be released soon. Product releases from Korea United Pharm and Colmar are also expected to follow. It is a pity for Ahn-gook Pharm, which has already received an item license and is waiting for release. Ahn-gook Pharm's patent extension period of 187 days was invalidated, and the launch was confirmed from August 30, 2021. it also obtained a generic exclusivity, and a monopoly on the generic market for nine months from the time of release. However, it is said that the competitors may use other strategies to preoccupy the generics market of Galvus.
- Policy
- Tightening electronic review on antiinfectives from October
- by Lee, Hye-Kyung Jun 09, 2020 06:28am
- Korea’s Health Insurance Review and Assessment Service (HIRA) is tightening the electronic review system regarding the antiinfectives for systemic use. The list of electronic review subjects include AbbVie Korea’s Mavyret, Gilead Science Korea’s Biktarvy, Ildong Pharmaceutical’s Besivo and many other chronic hepatitis type B and C treatments. To prevent drug overuse and abuse, HIRA sets down and uses electronic inspection criteria based on drug label (effect, benefit, dose and administration method) and reimbursement standard (issued by Ministry of Health and Welfare) established by Ministry of Food and Drug Safety (MFDS). When a drug is used not according to the approved indication and reimbursement criteria decided by MFSD, the electronic inspection system could automatically deduct the reimbursement. Xarelto and Pradaxa’s electronic inspection program would be developed following the drug label and electronic inspection criteria principle. And reimbursement deduction or other adjustment would be executed when incompliant with the drug label. Currently, the government is building the review programs on antiinfective drugs for systemic use including ATC code of J01, J02, J04, J05, H, P and L. Not only does Group J include hepatitis treatments, but also other various drugs like Chong Kun Dang’s Amoxapen, Yuhan’s Cefaclor, Dongwha Pharm’s Fucidin, Gilead Science’s Harvoni and Hanmi Pharmaceutical’s Hanmi Flu. Nocturnal enuresis treatments (Hanmi Pharmaceutical’s Demoresin, JW Shinyak’s Desonic) and hypothyroidism treatment (Bukwang Pharmaceutical’s Synthyroid, Kyowa Kirin Korea’s Regpara) are listed for reimbursement and categorized under Group H. From Group P, rheumatoid treatment (Elyson Pharm’s Oxiklorin, Korea PMG Pharm’s Duroc), and trichomoniasis treatment (Sinil Pharmaceutical’s Tinidazin, Austin Pharm’s Austin Tinidazole) would undergo the electronic review. Group H includes colorectal cancer treatment (Ildong Pharmaceutical’s Xelobig, Roche Korea’s Xeloda), chronic myelogenous leukemia treatment (Dong-A ST’s Gleenib, Boryung Pharmaceutical’s Glima, Chong Kun Dang’s Leukeevec) and non-small cell lung cancer treatment (Roche Korea’s Tarceva, Teva-Handok’s Teva Erlotinib). The basic principle of the electronic review relies on MFDS-approved indication—effect, benefit, dose and administration method—and other reimbursement standard would be reflected for the review. HIRA would complete building and introducing the program around June to September and enforce the electronic review from October. Healthcare institutes would have to properly cooperate with the government agency for all subject drugs to be prescribed and administered, appropriately.
- Policy
- AZ-China joint venture Dizal tests drug in Korea
- by Lee, Tak-Sun Jun 08, 2020 06:15am
- Dizal Pharma, a joint venture company by AstraZeneca and a Chinese firm, is initiating a clinical trial in Korea on non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) or human epidermal growth receptor 2 (HER2) mutation. The pharmaceutical industry is paying a close attention on the Chinese company’s clinical trial, as Hanmi Pharmaceutical and Takeda are also developing a treatment targeting both patient groups either with EGFR mutation or HER2 mutation. On June 5, Korea’s Ministry of Food and Drug Safety (MFDS) has approved of the transnational phase 1/2 clinical trial protocol on 'DZD9008,' submitted by a global clinical CRO firm Covance Korea. The clinical trial aims to confirm the safety, tolerability, pharmacokinetics and antitumor activity of DZD9008 in advanced NSCLC patients with EGFR or HER2 mutation. DZD9008 is an investigational anticancer agent in development by a Chinese-based company, Dizal Pharma. The pharmaceutical company is a joint venture company by a global pharmaceutical company AstraZeneca and China Future Industry Investment Fund (FIIF). In April last year, China’s National Medical Products Administration (NMPA) approved a clinical protocol on DZD9008, and soon after the joint venture company submitted an Investigational New Drug Application. EGFR mutation is frequently expressed in NSCLC patients and HER2 mutation in breast cancer patients. Targeted therapies for respective cancer types have been developed. However, a drug to cover both patient groups with EGFR or HER2 mutation has not been approved to date. In Korea, clinical trials on Hanmi Pharmaceutical’s poziotinib (phase 2 trial on NSCLC patients with EGFR or HER2 exon 20 mutation) and Takeda’s mobocertinib (phase 1/2 trial testing EGFR/HER2 inhibitor in NSCLC patients) are in progress at the movement. The clinical trial on DZD9008 would call for 44 participants in Korea (180 participants worldwide) and conducted in Catholic University of Korea—St. Vincent’s Hospital, National Cancer Center, Seoul Samsung Medical Center, Seoul National University Hospital and Seoul Asan Medical Center. So far, none of Chinese-based pharmaceutical company has made it in Korean market, and even a finished product from China is rare to find. But a couple of Chinese pharmaceutical companies are reportedly conducting clinical trials in Korea.
- Policy
- The copayment of Remdesivir is supported by the government
- by Kim, Jung-Ju Jun 08, 2020 06:11am
- While the government announced that it would make special imports of Remdesivir, which is being evaluated as COVID-19 treatment, the quarantine authorities said that the cost of treatment is likely to be paid by the NHIS, and the patient's cost of liability is likely to be paid by the government. Eun-kyung Chung, the head of the Central Disease Control Headquarters, made a statement today (4th) regarding the special import of Remdesivir in the regular briefing Q&A. According to her, the current government has begun to negotiate a secured supply with Remdesivir for imports. In this process, the drug price will be decided, it has not been determined how much will be secured and how much it will cost. However, since this drug will be brought into Korea in the form of an orphan & essential Drug, the cost of this drug is likely to be borne by the health insurance finances and national finance. "This drug is an orphan & essential Drug, so the government will secure it and proceed with treatment in consideration of indications," said she. "Currently, COVID-19 is the first-class infectious disease. The charges are borne by NHIS and it is highly likely that the patient's co-payment will be enforced by the country." She said that detailed guidelines will be summarized and announced when plans to secure products such as drug prices and volumes become detailed in the future.
- Policy
- Court dismisses request to revoke Galvus IMD approval
- by Lee, Tak-Sun Jun 08, 2020 06:11am
- Novartis’ request to revoke Korea’s Ministry of Food and Drug Safety (MFDS) approving Hanmi Pharmaceutical’s Vildagle (vildagliptin hydrochloride) has reportedly been dismissed. In May, Novartis has filed a litigation to cancel a drug approval on Vildagle 50 mg tablet, claiming the Korean-made drug did not fulfill the duty to notify the patent owner when processing the item approval. On June 4, the industry reported Seoul Administrative Court has dismissed Novartis’ request to nullify the drug approval. Although the court did not disclose the reason behind the decision, the industry suspects the lack of precedent canceling the ministry’s approval has played a part. Novartis As a result, MFDS’ approval on Vildagle 50 mg tablet would be sustained. Hanmi Pharmaceutical’s Vildagle has been approved by MFDS on Jan. 21 as an incrementally modified version of Novartis’ DPP-4 antidiabetic drug Galvus tablet (vildagliptin). Hanmi Pharmaceutical received the approval except on the indication that Galvus extended the original’s substance patent for. The Korean company argues the drug has evaded the substance patent to be expired on Mar. 4, 2022. Currently, the Intellectual Property Trial and Appeal Board is reviewing the case. Novartis, on the other hand, states the approval on Vildagle was not fairly process, as Hanmi Pharmaceutical disregarded the duty to notify the patentee according to the drug approval-patent linkage system. However, Hanmi Pharmaceutical and MFDS refute the Korean company was not required to notify the multinational company as the item did not infringe the original’s patent. Regardless of the court dismissing the request, Novartis plans to continue addressing the dispute during the litigation. After receiving a pricing of 403 won per tablet in April, Hanmi Pharmaceutical is contemplating on the launch of Vildagle. And Novartis has already filed litigation on patent infringement and injunction against Vildagle before the launch.
- Policy
- Abbvie’s Rinvoq was approved
- by Lee, Tak-Sun Jun 05, 2020 06:10am
- Another oral rheumatoid arthritis drug has been approved in Korea. It is Abbvie’s Rinvoq sustained-release tablet 15mg (Upadacitinib). The competing drugs include Pfizer’s Xeljanz (Topacitinib), Lilly' Olumiant (Baricitinib), and Astellas' Smyraf (Peficitinib). On the 4th, the MFDS approved Abbvie’s Rinvoq 15mg as a new drug. It is used to treat moderate to severe active rheumatoid arthritis in adults who do not respond appropriately to one or more anti-rheumatic agents (DMARDs) or who are intolerant. It can also be administered alone or in combination with Methotrexate or other non-biological anti-rheumatic agents (DMARDs), but not with biological anti-rheumatic agents (DMARDs) or other Januskinase (JAK) inhibitors. It is a drug that is administered orally 15 mg once a day regardless of meals. It is more convenient to use than the TNF alpha-blocking injection that is commonly used in rheumatoid arthritis patients. In five cases of Phase III trial, Rinvoq proved effective in rheumatoid arthritis patients. In addition, the response rate was higher than that of the control drug such as MTX monotherapy or placebo group. In Korea, there are a lot of oral drugs of the JAK inhibitor series, such as Rinvoq, Pfizer's Xeljanz, Lilly's Olumiant, and Astellas' Smyraf. They have been approved in Korea and are on the market. Xeljanz recorded sales of ₩14.7 billion based on IQVIA last year, and is competing with TNF alpha blocker in the antirheumatic arthritis market. Olumiant recorded ₩2.2 billion in the market last year. Sales of oral JAK inhibitors are expected to increase significantly if Astellas' Smyraf which was approved in January and Abbvie’s Rinvoq are released in the domestic market.
