- Policy
- Amgen's Eylea biosimilar has been approved for Phase III
- by Lee, Tak-Sun Jul 2, 2020 06:10am
- Amgen is conducting a phase III clinical trial on Eylea biosimilar in Korea. Recently, Samsung Bioepis' Eylea biosimilar has also been approved for phase III clinical trials in Korea, so the Korean market is expected to face strong competition between Big Pharma and native biosimilar companies. On the 29th of last month, the MFDS app
- Company
- Lee Heeseung to oversee MA-GA-PR at MSD Korea
- by Eo, Yun-Ho Jul 2, 2020 06:09am
- A former senior director at Novartis Korea, Lee Heeseung is to be appointed as a leader of the External Affairs department at MSD Korea. According to the pharmaceutical industry sources told the latest personnel decision by MSD Korea. Lee Heeseung would take over the position of External Affairs Lead from July 15. Three teams includi
- Policy
- MFDS-EMA, temporary confidentiality agreement for COVID-19
- by Lee, Jeong-Hwan Jul 2, 2020 06:08am
- The MFDS announced on the 30th that it had temporarily signed a confidentiality agreement with the European Medicines Agency (EMA) when exchanging information for the diagnosis, prevention and treatment of related infectious diseases including COVID-19. This agreement has the significance of establishing a close information exchange system
- Policy
- Pharmaceutical coverage list updated with Xolair and Akave
- by Kim, Jung-Ju Jul 2, 2020 06:08am
- As an allergic asthma treatment Xolair injection (omalizumab) was newly listed, the detailed criteria for healthcare reimbursement was also updated. Also the reimbursement standard on hypertension and hyperlipidemia combination drug added new ‘fimasartan plus atorvastatin’ combination due to the new listing of Akave tablet. Korea’
- Company
- Nicetile's Rx has decreased by 40% over the past year
- by Chon, Seung-Hyun Jul 2, 2020 06:08am
- Sales of 'Acetyl-L-Carnitine (ALC)', a brain function improving agent, fell sharply. As a result of clinical re-evaluation, the market size has decreased by 40% in one year as indications have been reduced. The market for 'Choline alfoscerate', which is predicted for clinical re-evaluation, is also expected to change depending on the results.
- Policy
- α-GPC can be adjusted in advance up on to clinical plan
- by Lee, Tak-Sun Jul 1, 2020 05:56am
- The MFDS announced its position for the first time in the clinical re-evaluation of 'Choline alfoscerate', a brain function improving agent. The MFDS said there were no procedural issues related to this evaluation, and the duration or number of tasks will be decided after the clinical plan is received. However, it emphasized that approval
- Opinion
- [Reporter’s view] Listed drug reevaluation, now what?
- by Lee, Hye-Kyung Jul 1, 2020 05:56am
- The Korean health authority issuing a statement on reducing choline alfoscerate coverage is just a beginning. On June 11, Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) announced the decision to raise the patient copayment rate on choline alfoscerate, which has been covered by the Na
- Company
- European license for Avastin biosimilar is imminent.
- by Chon, Seung-Hyun Jul 1, 2020 05:55am
- Samsung Bioepis said on the 28th (local time) that it received a positive opinion on the approval of ‘Avastin biosimilar, Aybintio' from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). It received positive feedback from the CHMP about 11 months after the launch of EMA's marketing authori
- Opinion
- [Reporter’s view] Unpredictable authorized generic policy
- by Lee, Tak-Sun Jul 1, 2020 05:54am
- The MFDS is planning to disclose the 'generic competitiveness strengthening plan' discussed through the public-private association in the near future. Some negotiated content has been reported. However, the main part of the generic policy seems to be known only when the final proposal is issued. The industry believes that the impact on the
- Policy
- MFDS lifts nizatidine sales ban, Alvogen cancels license
- by Lee, Tak-Sun Jul 1, 2020 05:54am
- Alvogen Korea has reportedly cancelled the item license on its nizatidine drug, although its sales ban for containing the unacceptable level of cancerous NDMA was listed. The case proves lifting the sales ban and a company’s will to sell the product are two different matters. On June 25, Korea’s Ministry of Health and Welfare (MOHW
