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- 2026-04-15 15:34:46
- Policy
- Atozet’s generics are approved
- by Lee, Tak-Sun Feb 19, 2021 06:17am
- AtozetGenerics for Atozet (Ezetimibe/Atorvastatin, MSD Korea) were approved on the 18th. Dongkoo Bio, which had joined the Chong Kun Dang group, was also approved. It is reported that Dongkoo Bio transferred and acquired the existing licensed items and newly licensed generic for Atozet according to the license regulations. On the 18th, the MFDS approved a number of generic drugs of Ezetimibe/Atorvastatin. All of them are products that have been tested for bioequivalence using the original drug Atozet as a reference drug, and are products that were applied for approval on January 23, after re-examination. Pharmaceutical companies such as Yuhan, Daewoong, and Ildong are included. It also included Dongkoo Bio, Jinyang, and Dasan, which conduct bioequivalence tests and commission production to other companies. In particular, Dongkoo Bio attracted attention. Dongkoo Bio has been preparing generic drugs and recruiting consignment companies, but was detested from consignment companies as they suddenly entered the data submission drug group preoccupied by Chong Kun Dang. In January, Dongkoo Bio’s Atoeve was approved, the same ingredient, through data sharing with Chong Kun Dang. However, Dongkoo Bio transferred Atoeve to Hwail, and Dongkoo Bio’s Jetstan, generic for Atozet, was approved. Kuhnil, Young Poong, and TDS pharm have succeeded in obtaining approval for generics manufactured by Dongkoo Bio. It is known that the approval regulations of the MFDS were affected by Dongkoo Bio's transfer of the existing licensed items to other companies and the approval of generic products. This is because in order for the consignment bioequivalence item to be proved bioequivalence, the consignment item must also obtain permission. Dongkoo Bio had a plan to obtain approval for its own products early through Chong Kun Dang Group, and to produce only consigned items for direct development generics. This is because if Dongkoo Bio joins Chong Kun Dang Group, it will be possible to receive preferential treatment at drug prices over generics by entering within 20 of the same ingredients under the stepped drug price system. However, it is said that it was impossible due to the regulations of the MFDS. Under the current stepped drug price regulation, if more than 20 identical drugs are listed, the upper limit of newly listed items is reduced to 85% of the existing lowest price. Generics for Atozet already have more than 20. Therefore, the drug price is also determined according to the lowest price item that applied for the drug price in January. Generic companies are worried about whether there will be a data-submitted pharmaceutical company that has intentionally listed the drug price at a low price so that competitors have applied for a lower drug price. Regardless of this, the market is concerned about overheating competition as dozens of Atozet’s generics are pouring out. Usually, when the competition for generics is severe, illegal rebates have also been on the rise.
- Company
- Meditoxin and Innotox back for sales, but what about safety?
- by Feb 19, 2021 06:17am
- Although the Ministry of Food and Drug Safety (MFDS) ordered a license revocation on Medytox’ botulinum toxin drugs, they would be back on the shelf and available for sales as the court halts the administrative action. The relevant industry insiders are pointing out MFDS should be more thorough with pre-sales lot release approval for the people’s health and safety. In late 2019, MFDS ordered the company to shorten the expiration date due to safety issues, and imposed an item approval revocation on Meditoxin in June 2020, when it was found to have used unapproved ingredient and manipulated submitted national lot release review material. The ministry also revoked the license on a liquid type botulinum toxin Innotox in last January, because of safety validation evidence. But regardless of the order, Medytox can still sell these drugs now. The court accepted the company’s request for the administrative order suspension. The Daejeon District Court halted the administrative order until the 30th day from the day the decision is made. A biologic drug, botulinum toxin has to receive MFDS’ national lot release approval before selling. The approval is reviewed to ensure safety and efficacy in each lot of the biologic drug, which should be strictly managed to avoid contamination. As the national lot release review is conducted immediately after manufacturing and before distributed to the market, the review cannot ensure the product’s safety exposed to a risk during the destruction process. Especially if the safety evidence was manipulated, the product’s safety cannot be ensured until which point, and consumers would be clueless as to when the product to be administered to a patient is manufactured. A pharmaceutical and bio industry insider expressed concern and commented, “The court reportedly decided to suspend the administrative order to prevent the company from unrecoverable damage. But if the product, before fixing its safety issue, gets distributed, unexpected adverse reaction could happen.” Also there is an issue of fairness. Kolon Life Science’ Invossa had its license revoked due to suspected evidence manipulation, and the court refused to accept the company’s request to suspend the administrative order due to potential risk in safety. Since the Invossa incident, MFDS firmly stated there would be no tolerance for such evidence manipulation, and the ministry reconsolidated the principle with Meditoxin incident. Another industry insider noted, “The court’s decision to suspend the administrative order does not assure safety. MFDS needs to stringently review products to meet the objective of the national lot release review and to assure safety in the people.”
- Policy
- Korean-made COVID-19 treatment Rekirona distributed
- by Kim, Jung-Ju Feb 19, 2021 06:17am
- Celltrion has started supplying the first South Korean-made COVID-19 monoclonal antibody treatment Rekirona to healthcare institutes from Feb. 17. Rekirona is a first COVID-19 antibody treatment developed and manufactured in South Korea and it was approved by the Ministry of Food and Drug Safety (MFDS) with condition to further submit clinical data. The company stated it completed manufacturing doses for 100,000 people to treat patients in the country, and it plans to annually manufacture doses for 1.5 million to 3 million people, depending on the demand. MFDS indicated the drug to treat patients confirmed to have COVID-19, within seven days of the diagnosis, who are aged over 60 without the need of oxygen therapy, or have underlying diseases like cardiovascular disease, chronic respiratory disease, diabetes, hypertension, or pneumonia. The details of the treatment supply would be informed to each healthcare institute by related city and province office. Celltrion’s subsidiary Celltrion Pharm owns the sales rights in the country, and it would be in charge of supplying the treatment nationwide.
- Policy
- The first generic of birth control pills Yaz is released
- by Lee, Tak-Sun Feb 19, 2021 06:17am
- YazThe first generic for Yaz, a pre-contraceptive drug that has established itself in the market, and Duowell’s generic, a combination drug for hypertension and hyperlipidemia, was released. Generic for Yaz is the first with the same ingredients as the original, but in the case of Duowell’s generics, the same ingredient formulations are already available as drug for data-based re-evaluation. The MFDS approved Hyundai’s Yarose and Kolmarpharma's Telovatin on the 16th. Yaroz is the first generic in Bayer's pre-contraceptive drug Yaz (Drospirenone/Ethinyl estradiol). Hyundai proved equivalence in a bioequivalence test using Yaz as a reference drug. Yaz is the drug with the highest sales value in the domestic pre-contraceptive market. In 2019, IQVIA sales amounted to ₩14.4 billion, which outpaced the rival drug Mercilon (₩9.1 billion) by a big gap. However, Yaz is a Rx drug, so its distribution channel is different from that of the OTC drug Mercilon. Therefore, pharmaceutical companies are commercializing Mercilon as a competitive drug rather than Yaz. Hyundai is the No. 1 pharmaceutical company in the market for post-mortem contraceptives that require a doctor's prescription, such as Ellaone and Norebwon. Although it is releasing pre-contraceptive pills in the OTC market, it is far from the leading market. It is analyzed that Hyundai, which has a distribution channel for hospitals and clinics as a post-contraceptive drug, will have a competitive edge in the pre-contraceptive drug market with the generic of Yaz, an Rx drug. Hyundai has been working on Yaz's patent challenge for about 4 years. However, the patent challenge was not successful. Then, when Yaz's patent expired in August last year, it became possible to develop and release generic drugs. DuowellKolmarpharma's Telovatin is also the first generic to conduct a bioequivalence test using Duowell as a reference drug. This drug is a combination of Rosuvastatin and Telmisartan. Generics for Rosuvastatin-Telmisartan have already been approved by more than 20 companies and has been released on the market. Ildong, which was licensed for drug for data-based re-evaluation, shared the data, and multiple pharmaceutical companies received permission before PMS (re-examination). Duowell's PMS expired on October 30th. Kolmarpharma’s Telovatin, which was approved this time, is the first generic drug that has been applied for approval after the end of PMS. Generics are expected to be much cheaper than existing generics due to the stepped drug price system. If the drug price is low, sales are detrimental, but it is expected that generics that appeal to low drug prices will continue to emerge in a situation where market competition is severe.
- Policy
- AZ vaccine for 780,000 people will be inoculated
- by Lee, Tak-Sun Feb 18, 2021 06:28am
- AstraZeneca's COVID-19 vaccine, which starts vaccination on the 26th, received lot release from the MFDS. As a result, it is delivered from the factory and administered at each inoculation site. The lot-released vaccine is expected to be effective until June, and the KCDA plans to complete the vaccination until May. On the 17th, the MFDS approved lot release for 5 serial numbers of AstraZeneca Korea's COVID-19 vaccine. The total amount is about 1,574,000 doses, and considering that the vaccine is given twice, it is for 787,000 people in total. All of the contracts between AstraZeneca and the government, which will be inoculated in the first quarter, have been lot released. It is manufactured by SK Bioscience in Korea. The expiration date of the product released this time for lot release is mid-June. The KCDA has a policy to complete the second vaccination by May to the targets for the amount of vaccination, so the short expiration date is not expected to be a problem. The KCDA plans to inoculate this vaccine to ▲geriatric hospitals and nursing facility residents and workers (approximately 272,000 people) ▲high-risk medical institution workers (approximately 362,000 people) ▲COVID-19 first responders (approximately 78,000 people). However, elderly people over 65 years of age are not eligible for vaccination. Nursing hospitals and nursing facility residents and employees will receive the first vaccination from the 26th. It is expected that the first inoculation in Korea will come out of this group. The KCDA plans to complete the first vaccination of the subjects receiving the AstraZeneca vaccine in the first quarter by March, and the second vaccination by May. The interval between the first and second doses of the AstraZeneca vaccine is 4 to 12 weeks. The KCDA concluded that the second vaccination will be administered approximately 8 weeks after the first vaccination. The MFDS completed the lot release in 20 days, which usually took 2-3 months. For rapid lot release, Approval and lot release were simultaneously performed. The quantity of this lot release was produced before approval on the 10th. An official from the MFDS explained, "the quantity produced in advance to obtain permission is also included." An official from the MFDS explained, "All of the lot released quantities have been approved, and there will be additional lot releases according to the inoculation plan in the future." AstraZeneca vaccine will be supplied to 10 million people this year (excluding COVAX Facility quantities).
- Company
- 19 Korean companies to challenge Entresto patent
- by Kim, Jin-Gu Feb 18, 2021 06:25am
- A series of South Korean pharmaceutical companies are challenging the patents on Novartis’ heart medicine Entresto (sacubitril, valsartan plus sodium salt hydrate complex). Starting with Elyson Pharm filing a patent trial as a first in last year, 18 other companies expressed their intention to release their generics early. According to a pharmaceutical industry source on Feb. 16, South Korean pharmaceutical companies like CTC Bio, Boryung Pharmaceutical, Yuyu Pharma, Corepharm Bio, Kyperion, MFC, Sinil Pharmaceutical, Daewon Pharmaceutical, Yooyoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-gook Pharm, Hanmi Pharmaceutical, Chong Gun Dang, Daewoong Pharmaceutical, Genuonesciences, Samjin Pharmaceutical and Kolmar Pharma submitted a patent trial request from Feb. 9 through 15 and joined the race to challenge Entresto patent. Same as Elyson Pharm that started the process earlier, the group of South Korean pharmaceutical companies have filed a negative scope confirmation on Entresto’s crystalline form patent. Currently, total four patents are listed under Entresto brand. Aside from the crystalline form patent to be expired on Sept. 21, 2027, the drug has a product patent expiring in July 2027 and two composition patents expiring January 2029. For an early release of the Entresto generic, the group of South Korean companies would have to also overcome other outstanding patents. By successfully evading the four patents, the follow-on drug companies would be able to launch their generics after April 13, 2022, when the original drug’s post-marketing surveillance (PMS) ends. Norvatis released Entresto, a hard-to-treat heart failure drug, in the South Korean market in October 2017. In the first year of launch in 2018, the drug generated 6.3 billion won from outpatient prescription, and the sales tripled in just two years in last year making 20.3 billion won. South Korean companies have been highly interested in such profitable market for their Entresto generics. Some companies have reportedly initiated bioequivalence test. A pharmaceutical industry associate told, “As Elyson Pharm challenged Entresto patent first, other companies planning to release generics early are also trying to overcome the patent.”
- Company
- SK Bioscience has signed a technology transfer contract
- by Kim, Jin-Gu Feb 18, 2021 06:24am
- SK Bioscience has secured the right to independently produce it in Korea by transferring the technology of Novavax vaccine. SK Bioscience announced on the 16th that it has licensed NVX-CoV2373 and signed a contract with the KCDA to supply 40 million doses of vaccine respectively. SK Bioscience announced on the 16th that it has signed a technology transfer (License In) contract with Novavax for COVID-19 vaccine NVX-CoV2373, and 40 million dose vaccine supply contract with the KCDA. SK Bioscience signed a CDMO (Contract Development & Manufacturing Orgainzation) contract with Novavax in August last year. Since then, it has completed the transfer of vaccine manufacturing and process technology and is conducting commercial production for global supply. It is expected that the domestic supply through this contract will be able to start production immediately. Novavax vaccine uses a synthetic coronavirus spike protein to teach the immune system to produce antibodies that can deactivate the coronavirus. It has proven its long-term safety and effectiveness by being used in existing vaccines such as flu, hepatitis B, and cervical cancer vaccines. Unlike mRNA vaccines that are managed at a cryogenic temperature of -20 to -70°C, this vaccine can be stored refrigerated at 2 to 8°C, so it can be distributed using the existing vaccine distribution network. Recently, the clinical results of Novavax vaccine have been published. Novavax announced last month that Phase III clinical trial of NVX-CoV2373 conducted in the UK in 15,000 adults aged 18 to 84 showed an average of 89.3% preventive effect. The original COVID-19 that did not mutate was 95.6% more effective than the mRNA vaccine, which is considered to be the most effective. For the UK mutant virus and the South African mutant virus, the first vaccines currently under development were confirmed to be 85.6% and 60% respectively. Stanley C. Erck, CEO of NovaVax, said, "We are pleased to expand the partnership we have established for the global supply of NVX-CoV2373 with this agreement." He said, "We are sharing the urgent need to provide a safe and effective COVID-19 vaccine to humanity around the world, including Korea." Ahn Jae-yong, CEO of SK Bioscience, said, "It is of great significance that we have taken the initiative to overcome the pandemic at the national level by securing the technology itself, not simply by purchasing products." He said, "We will work with the government so that our people can get COVID-19 vaccine quickly."
- Policy
- AZ vaccine, the first inoculation in Korea from the 26th
- by Kim, Jung-Ju Feb 18, 2021 06:24am
- The domestic schedule for the COVID-19 vaccination treatment made by AstraZeneca has been confirmed. The government plans to fully implement vaccinations from the 26th, but plans to accumulate and determine additional clinical information for those over 65 years old people. Inoculation of AZ vaccine to the elderly over 65 is virtually withheld. Pfizer vaccine is given first by medical staff in charge of COVID-19 treatment as early as this month to next month. Jeong Eun-Kyeong, head of the COVID-19 Vaccination Response Promotion Team, briefed today (15th) on the COVID-19 vaccination plan. According to her, starting from the 26th, those working in geriatric hospitals and nursing facilities under the age of 65 will be given AZ vaccine first. The government estimates that there are 270,000 people. For the elderly aged 65 or older, the timing of vaccination is determined through a review of the Korea Advisory Committee on Immunization Practices (KACIP) after confirming additional clinical information on vaccine efficacy. Regarding the reason for this restriction of vaccination to the elderly over 65, she said, “The safety of AZ vaccine are clear. There is a concern that the controversy on the efficacy of the elderly over 65 will lower the vaccination rate of the public and medical personnel." Pfizer's COVID-19 vaccine will be introduced at the end of this month or early March through the COVAX Facility. This product will be vaccinated by 55,000 medical staff who treat COVID-19 patients. About 350,000 workers in medical institutions such as general hospitals, as well as 78,000 first-line responders such as COVID-19 quarantine agents and epidemiological investigators are scheduled to receive the AZ vaccine from March.
- Company
- Does Propecia cause depression?
- by Eo, Yun-Ho Feb 17, 2021 05:40am
- It has already been reflected in the package insert such as Korea and Europe, and has not been directly proven to have a causal relationship. There was another controversy that the hair loss drug Propecia causes depression. Reuters reported on the 3rd (local time) of the lawsuit filed in the Brooklyn Federal Court of New York in connection with the side effects of Propecia. Since 2009, more than 200 cases of depression among people taking Propecia (Finasteride) have been received, and the developer MSD (Merck, USA) has covered up this. After the report, numerous Korean media spread the content, and in fact, there were even reports that Propecia could cause depression and suicide. This is an exaggeration. Prediction causes controversy, and controversy distorts facts. No one can define as 'true' in the current situation. The issue is whether MSD has concealed the reported adverse reaction cases and prevented the information from being reflected in US permits. Reports of abnormal cases cannot prove a causal relationship with the product. It cannot be concluded that the drug is the cause of the adverse event because an abnormal event has occurred after taking the drug. Brigham and Women's Hospital in US, for example, published an analysis that suggests that Propecia, a mechanism that inhibits the enzyme, may be associated with depression, based on the low levels of Allopregnanolone produced by the 5-alpha-reductase in male depressed patients. In a study published in the Dominican Republic of genetically followed patients with 5-alpha-reductase type 2 deficiency, there was also a study finding that there was no significant difference in depression or suicide frequency between the general population and the corresponding patient group. Kwang-sung Choi, chairman of Korean Hair Research Society (Professor of Dermatology at Inha University Hospital) said, "The reports of adverse reactions from Propecia mentioned in foreign news articles are the cumulative number of voluntary reports related to depression that occurred around the world for about 10 years since its launch in the US in 1998." He said, “Adverse reactions such as depression or suicide risk can be complexed by social, psychological, and economic factors in addition to medical factors. Depression-related cases that have occurred to date are simply those that occurred while taking drugs or were reported voluntarily.” So, did MSD really 'cover up' the facts? It is an obligation, not an option, for pharmaceutical companies to collect and report adverse events after obtaining marketing approval from health authorities and distributing them. The WHO's global adverse reaction database,'VigiBase', has already reported cases of Propecia's depression and mood swings. As mentioned by Reuters, cases of adverse reactions reported in Europe and Canada are already reflected in licenses and product manuals, and the MFDS also inserted the phrase 'depression and mood swings including suicide thoughts' in 2017. No country has stipulated that Propecia causes depression or mood swings. Taken together, it means that MSD has only concealed the phrase inserted in the permits already reflected in many countries in the US. It is also a drug that has been prescribed for over 20 years. Rather than taking the side of MSD, if it intentionally conceals facts, its morality should be blamed. In Korea, many people with hair loss are taking Propecia and are trembling with anxiety over this controversy. Chairman Kwang-Sung Choi said, "Propecia is a Rx drug. Hair loss diseases can be effectively and safely treated by treatment and prescription by specialists, and side effects are also managed through treatment. It is more damaging to stop hair loss treatment or receive the wrong treatment due to excessive fear of side effects or unproven claims.”
- Policy
- AstraZeneca Korea earns Consignment Business Authorization
- by Lee, Tak-Sun Feb 17, 2021 05:40am
- AstraZeneca Korea earned the seventh ‘Pharmaceutical Consignment Manufacturing Business Authorization’ in South Korea due to the COVID-19 vaccine manufactured by SK Bioscience. South Korea’s Ministry of Food and Drug Safety (MFDS) reported AstraZeneca Korea has been authorized for a pharmaceutical consignment manufacturing business on Feb.10. On the same day, the South Korea’s first approved COVID-19 vaccine, ‘AstraZeneca Korea Covid-19 Vaccine injection’ was also authorized for the market. The licensor of the vaccine is AstraZeneca Korea, but it would be manufactured by SK Bioscience. Prior to receiving a pharmaceutical license, the supplier has to be licensed as a manufacturer or an importer. And an approved manufacturer in South Korea can apply for an approval on domestically marketed drug or export-only drug. A company licensed as an importer can also apply for an approval on an internationally imported drug. So far, AstraZeneca Korea was only licensed as a pharmaceutical importer in South Korea as of 2016. Up until Feb. 10, the multinational company had total of 65 licensed drugs all imported. But the company needed another business license as it manufactures the COVID-19 vaccine authorized on Feb. 10 since last July through a consignment deal signed with SK Bioscience. In 2007, MFDS newly established the Pharmaceutical Consignment Manufacturing Business Authorization for such company without a manufacturer in South Korea to receive the pharmaceutical authorization. With the license, a company can apply for an approval on an item manufactured with consignment contract. The first authorization was earned by GL Pharm Tech (CEO Wang Hunsik) in September 2008. The company owns licenses over four items including G-Soren tablet, manufactured by Richwood Trading Company. Another multinational pharmaceutical company MSD Korea (CEO Kevin Peters) also took the second authorization in 2009. MSD Korea owns licenses over three items including an anti-hypertension drug Cozaar XQ tablet, manufactured by Hanmi Pharmaceutical. Corepharm Bio, Crystal Genomics, Abbott Korea, Geongang Pharmaceutical and AstraZeneca Korea are the rest of companies with the consignment business authorization. Other companies to supply COVID-19 vaccine should be licensed in South Korea. Pfizer and Janssen have no issue as they are already licensed as an importer, and would import their vaccines. But for Novavax, who licensed out the technology to SK Bioscience, would have the South Korean company to be in charge of the approval and distribution. As for a company without a license in the country like Moderna, it would have to open a branch in South Korea to apply for the imported vaccine use authorization, or to license out for the co-promotion deal to a Korean company like Novavax.
