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- 2025-12-25 13:58:17
- 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.
- 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).
- 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.
- 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.
- Policy
- Hanmi’s salt-modifying drug for Galvus, re-licensed
- by Lee, Tak-Sun Feb 17, 2021 05:39am
- Hanmi, which failed to enter the market for Vildagliptin through so-called split indications, has obtained item approval again. The MFDS approved Vildagle Tab 50mg (Vildagliptin HCl) by Hanmi on the 10th. It was licensed in January of last year, and Vildagle Tab 50mg, which was voluntarily withdrawn in July of that year. The withdrawn item is used as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetes patients. It was approved for four types of treatment: ▲ single therapy ▲ Metformin combination therapy ▲ Sulfonylurea and Metformin combination therapy ▲ Insulin alone or Metformin combination therapy. However, in addition to the four methods of use, this product has added sulfonylurea or metformin or thiazolidinedione co-administration. The scope of efficacy and effect has become the same as the original drug, Novartis' Galvus. Hanmi previously established a Galvus patent avoidance strategy with a product with a reduced range of usage. Insurance benefits were obtained, but the strategy needed to be revised because he lost the patent lawsuit. It was withdrawn, and re-approval was obtained with the same efficacy and effect this time. In the case of Vildagliptin, original Novartis products and products by Ahn-Gook and Hanmi are licensed. Ahn-Gook's product is Vildagliptin, the same as the original Galvus. Ahn-Gook acquired generic exclusivity through the success of the first patent challenge, and the sale of the same active ingredient was banned from August 30, 2021 to May 29, 2022, but Hanmi's salt-modifying drug for Galvus is not applied. Not only Ahn-Gook, but also Hanmi succeeded in the first patent challenge, but did not succeed in the second patent challenge. In the first (the KIPO) challenge, Galvus' material patent period was reduced by 187 days through a trial for invalidation of the extended duration, but in the second (Patent Court of Korea) challenge, only 55 days were recognized as invalid. Therefore, it must be released later than in August this year, which was originally planned for the release date. It is a burden that other generics are developing their products in line with the material patent end date of March 4, 2022. This is because it is advantageous to preoccupy the generic market by promoting product release as much as possible. Currently, Ahn-Gook and Hanmi's patent challenge was contested in the Supreme Court due to Novartis' appeal. Depending on the final outcome of the Supreme Court, the strategies of the two companies to dominate the market are expected to change.
- Policy
- Novavax vaccine needed as AZ vaccine in 65 and up postponed
- by Lee, Tak-Sun Feb 16, 2021 06:08am
- The South Korean government seems to be considering on purchasing more doses of other COVID-19 vaccine options as the government has decided to hold off on inoculating the age group over 65 with AstraZeneca’s vaccine. Originally, the 65-and-up age group was supposed to be vaccinated within the first quarter, but it has been pushed to the second quarter. And now the need for Novavax vaccine is heightened. On Feb. 15, Korea Disease Control and Prevention Agency (KDCA) disclosed the first quarter COVID-19 vaccination plan. The agency official said 272,000 occupants and inmates aged under 65 admitted to long-term nursing hospital or houses and related workers would be vaccinated first from late February, followed by 352,000 high-risk healthcare providers, 78,000 COVID-19 first responders including 119 emergency service, epidemiologist and disease control workers, and 55,000 COVID-19 patient-treating hospital workers. The government has secured AstraZeneca vaccine doses for 702,000 people and Pfizer vaccine doses for 55,000 people. The age group over 65, initially planned to be vaccinated within the first quarter, would have to wait until the second quarter due to insufficient efficacy data on AstraZeneca vaccine. About 370,000 people’s vaccination schedule would be pushed from the first to second quarter. However, the delay could cause a vaccine shortage in the second quarter as the number of eligible subjects would soar. And to prepare for the shortage, the South Korean government would need to additionally purchase more vaccine doses. Also, the government should be concerned the expected date of AstraZeneca’s vaccine efficacy confirmation in the elderly group is unknown, and predictability in vaccines developed by Janssen and Moderna is unreliable as well. Accordingly, the South Korean government is working on purchasing additional doses of Novavax vaccine with completed clinical trial in the U.K. Currently, SK Bioscience is manufacturing the Novavax vaccine under a consignment contract. The two companies have reportedly working on a licensing agreement as well. If the license-in deal gets sealed, the government plans to purchase additional doses for 20 million people from SK Bioscience. Recently, Novavax presented data on clinical trial with satisfying level of efficacy in the 65-and-up age group. The trial tested the vaccine on 15,000 people in the U.K. ranging from age 18 to 84, in which 89.3 percent of them demonstrated a successful preventive effect. 27 percent of the participants aged over 65 also showed successful rate. Meanwhile, AstraZeneca’s vaccine showed only 7.4 percent response rate in participants aged over 65, not enough to confirm the efficacy in the age group. But if the South Korean government is to procure additional doses of Novavax vaccines, the vaccination gap in the elderly age group created by AstraZeneca’s vaccine could be filled. The government sees that Novavax vaccine could be introduced in the second quarter at earliest. Director Jeong Eun-kyeong of KDCA briefed that “The South Korean government has almost reached the final stage of signing a contract for the additional Novavax vaccine doses. The vaccination for the age group over 65 would start when the COVAX-AstraZeneca vaccine, Novavax vaccine and other vaccine supply schedules are set.” Nevertheless, Novavax vaccine also has its own uncertainty. First, the company has to complete the license-out deal with SK Bioscience. Moreover, other countries’ emergency use authorization application for Novavax vaccines should be processed in March at earliest. The government’s plan to introduce the vaccine in May would be possible only if all the expected schedules proceed without an issue. Regardless of the uncertainty, Novavax vaccine has comparatively less uncertainty than other imported vaccines as they are manufactured domestically. Imported vaccines tend to have more unforeseen issues in approval date and supply. MFDS has already conducted a preliminary review on Janssen’s vaccine to be supplied in the second quarter, but the ministry has not reported any update on Moderna vaccine. And because they would be manufactured outside of South Korea, they would likely to struggle to supply the vaccines on schedule. The COVAX-Pfizer vaccine, which should have been introduced in mid February, has been delayed. Ultimately, Novavax vaccine should be secured to timely unfold the vaccination plan on the 65-and-up age group in the second quarter.
- Policy
- COVID-19 vaccine lot release to be authorized this week
- by Lee, Tak-Sun Feb 16, 2021 06:07am
- Minister of Food and Drug Safety Kim Gang-lip is explaining about the final authorization on AstraZeneca COVID-19 vaccine on Feb. 10. As a COVID-19 vaccine was authorized for the first time in South Korea, the lot release for AstraZeneca’s vaccine is expected to be granted this week. Although South Korea’s Ministry of Food and Drug Safety (MFDS) did not restrict inoculation on the age group over 65, the Korea Advisory Committee on Immunization Practices (KACIP) associated under Korea Disease Control and Prevention Agency (KDCA) is to make the final call. However, as a group of experts has decided the vaccine should also be accessible to population over 65, the advisory committee would be likely to follow the same direction. At the AstraZeneca COVID-19 vaccine authorization briefing presented on Feb. 10, the Minister of Food and Drug Safety Kim Gang-lip explained the lot release would be decided this week. Minister Kim said, “Currently, the lot release authorization procedure is ongoing. Probably the final decision would be made next week, and the authorization would be passed.” The lot release approval review would verify the quality and safety of the vaccine. And with the authorization, the vaccine would be available for the market. KDCA would finalize the AstraZeneca vaccine inoculation plan, including the details on the elderly group, by Feb. 19, and initiate the vaccination from Feb. 26. Minister Kim elaborated, “MFDS concluded the ministry could not find a reason to put a definite restriction on vaccinating the elderly group aged over 65 with AstraZeneca’s. However, warnings on the specific age group would be given at the clinical scene, and we expect KDCA to compile a reasonable guideline after surveying experts’ opinions and discussing with KACIP.” AstraZeneca’s COVID-19 vaccine was authorized for use in South Korea with a condition to provide additional data later. Minister Kim noted, “We have requested the company to submit interim and final reports on the currently ongoing clinical trial in the U.S. The trial is targeting 30,000 people, which includes about 7,500 elderly people.” The interim report should be submitted by the end of coming April.
- Policy
- Fosamax 10mg·Pletaal OD Tab has been withdrawn
- by Lee, Tak-Sun Feb 16, 2021 06:07am
- Otsuka MSD Korea's osteoporosis treatment Fosamax, and Otsuka Pharmaceutical's antiplatelet drug Pletaal OD Tab will be withdrawn from the Korean market due to poor performance. According to the MFDS on the 9th, as of the 8th, MSD Korea's Fosamax 10mg (Alendronic acid), Otsuka's Pletaal OD Tab 100mg, Pletaal OD Tab 50mg, and Pletaal Powder 20% (Cilostazol) have been withdrawn. Fosamax, original for Alendronic acid, is a bisphosphonate-based osteoporosis treatment and is widely used in Korea. Pletaal, original for Cilostazol also has a high market share in Korea for antiplatelet drugs. These items are not flagship items. Fosamax includes Fosamax 70mg, Fosamax PlusD, Fosamax Plus, and Fosamax 10mg, which has been withdrawn. Fosamax PlusD is MSD's flagship item. Fosamax PlusD recorded an outpatient prescription amount of ₩10.9 billion based on UBIST, ₩2 billion for Fosamax Plus, and ₩2.2 billion for Fosamax 70mg. There is no outpatient prescription sales of Fosamax 10mg because it is a non-reimbursement drug. Fosamax 10mg is taken once a day and Fosamax 70mg, once a week. Fosamax 70mg is highly preferred. Accordingly, MSD also focused on marketing Fosamax 70mg, and Fosamax 10mg was eventually converted to a non-reimbursement drug in 2018, and the prescription was virtually stopped in Korea. And this time with the withdrawal of the license, it was completely withdrawn from the market after entering Korea in 2008. Fosamax 10mg’s indication range is wider. This is because it is used for the treatment of osteoporosis by glucocorticoid (limited to postmenopausal women who did not take estrogen). It was eventually withdrawn from the market due to poor performance. Pletaal 50mg, Pletaal 100mg, Pletaal Powder 20%, Pletaal SR cap, Pletaal OD Tab 100mg, Pletaal OD Tab 50mg, and Pletaal SR cap 200mg are approved for domestic market. But, Pletaal Powder 20%, Pletaal OD Tab 100mg, and Pletaal OD Tab 50mg have been withdrawn. All drugs have been modified for convenience, but the strategy did not work well in the market. All three items are non-reimbursement drugs, and they have not been properly marketed. It was not difficult for Otsuka as products from other lineups are performing well in the market. Looking at the amount of outpatient prescriptions based on UBIST last year, other items excluding 3 items recorded ₩25.1 billion. There are many generics of Cilostazol on the market, but only the original has powder type and OD tablet type.
