- Policy
- 2nd GIFT drug Nefecon’s approval imminent in Korea
- by Lee, Hye-Kyung Oct 21, 2024 05:48am
- Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug last year, is close to receiving approval in Korea. According to industry sources on the 21st, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Nefecon. The completion of the safety
- Policy
- How to stabilize supply of national essential medicines
- by Lee, Hye-Kyung Oct 18, 2024 05:49am
- While prescribing drugs by ingredient name and introducing international nonproprietary names (INNs) are being discussed as measures to stabilize the supply of drugs, voices have emerged calling for a system that allows the use of the same ingredient drugs as nationally essential medicines. The issue of stabilizing the supply of not only
- Policy
- 'Can the Yoon administration develop blockbuster drugs?'
- by Lee, Jeong-Hwan Oct 18, 2024 05:49am
- Criticism has been raised that the government's policy to create global blockbuster drugs is not working and has a dark future. It has been pointed out that the difficulty in raising funds to support the R&D costs for pharmaceutical and biotech companies and ventures is causing financial difficulties for bioventures, and that expert hu
- Policy
- Gov't opposes to suspending reimb·ingredient prescribing
- by Lee, Jeong-Hwan Oct 17, 2024 05:52am
- The government has opposed the proposed measure, which aims to minimize the chaos in prescription·dispensing by suspending insurance reimbursement or blocking prescription code of drugs when substitute drugs are available. Suspending reimbursement of drugs covered by insurance is a temporary measure implemented in the case of administr
- Policy
- HIRA President, "Copayment ratio needs to be adjusted
- by Lee, Tak-Sun Oct 17, 2024 05:51am
- HIRA President Jung-Gu Kang said that the copayment ratio should be adjusted for anticancer drugs that lack verification of effectiveness. Kang said during the parliamentary audit by the Health and Welfare Committee, "We must lower the patient access hurdle and increase monitoring." Adding, "Especially because we evaluate high-cost drugs
- Policy
- Alvogen receives approval for its Humira biosimilar in KOR
- by Lee, Hye-Kyung Oct 17, 2024 05:51am
- A fifth Humira biosimilar has been approved in Korea. On the 15th, the Ministry of Food and Drug Safety approved Alvogen Korea's Simlandi pen40mg/0.4mL (adalimumab, recombinant), Simandi Prefilled Syringe Inj 40mg/0.4mL and 80mg/0.8mL.. Simlandi is imported and manufactured on consignment by Alvotech, a subsidiary of Alvogen Korea.
- Policy
- ‘Will raise ICER threshold for innovative new drugs’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has reaffirmed its policy to flexibly evaluate the ICER (incremental cost-effectiveness ratio) threshold for drugs that demonstrate innovativeness in order to strengthen patient access to new drugs. The intent is to increase the ICER threshold of new drugs based on previously announced criteria such as substitutability, pro
- Policy
- Govt ‘is considering measures to overcome Korea Passing’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has responded that it will come up with measures to ensure a stable supply of new drugs, including a dual pricing system, to overcome the so-called ‘Korea passing’ phenomenon, in which domestic and foreign pharmaceutical companies avoid launching their drugs in the domestic market and target overseas markets first, citing ex
- Policy
- Stopping illegal online sales·advertisements of 'Wegovy'
- by Lee, Hye-Kyung Oct 16, 2024 05:50am
- As 'Wegovy,' a dream treatment for obesity, is set to launch in South Korea, the health authority plans to focus on monitoring online illegal sales and fraudulent advertising. It will also implement post-marketing safety management related to side effects and drug abuse. The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) a
- Policy
- 'Will adjust the price of generic drugs through reevals'
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The Ministry of Health and Welfare responded to the NA’s inquiry on the ministry's policy operation plan to realize generic drug prices in Korea, explaining that the MOHW is promoting a plan to reduce and adjust drug prices through ‘external reference pricing re-evaluations.’ This means that the ministry will start the external referen
