- Policy
- New patent evasion strategy for Galvus follow-ons?
- by Lee, Tak-Sun Jan 14, 2020 06:28am
- A creative strategy to evade patent is attracting the pharmaceutical industry’s attention. If the strategy is found successful, pharmaceutical companies in Korea would be able to use it to evade the extended effective term of substance patent protection, as an alternative to the strategy of changing saline base of the original drug affi
- Policy
- Non-reimbursed Dupixent now covered with few conditions
- by Lee, Hye-Kyung Jan 14, 2020 06:28am
- Patients taking severe atopic dermatitis treatment Dupixent prefilled injection (dupilumab) as a non-reimbursement treatment option can now have an access to healthcare reimbursement without satisfying the newly established reimbursement criteria. Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) published a
- Policy
- Only 1 in 2 new drugs listed last year
- by Lee, Hye-Kyung Jan 13, 2020 11:30pm
- Of the 24 new drugs that were applied for benefits last year, 12 were successful in listed drugs, with the listing rate remaining at 50%. Dailypharm analyzed new drugs that were deliberated and voted by the HIRA's Pharmaceutical Benefit Committee last year. Of the 24 drugs, only 11 received reimbursed. The remaining 10 drugs were non-rei
- Policy
- Generic exclusivity for ₩50 million Betmiga applied
- by Lee, Tak-Sun Jan 13, 2020 06:26am
- The first generic drug of 'Betmiga' (Mirabegron, Astellas), a potent overactive bladder treatment, coming soon in June this year applied for permission. The interest in the industry is amplified because generic exclusivity are given exclusive rights to the generic market based on who first applied for the permit. According to the MFDS a
- Policy
- Certican price reduced by ATP to KRW 5250 for 1mg
- by Kim, Jung-Ju Jan 13, 2020 06:22am
- The price of Novartis’ immunosuppressant Certican (everolimus) was lowered on Jan. 9, as a result of the recent actual transaction price (ATP) survey on reimbursed drugs. The price could be further adjusted when the final decision is made from the administrative litigation between the company and government about ex-officio adjustment of t
- Policy
- More rare diseases designated for special case NHI benefit
- by Lee, Hye-Kyung Jan 13, 2020 06:22am
- From Jan. 1 this year, the government expanded list of designated rare diseases and healthcare institutes examining rare disease eligible for the special case healthcare benefit. To reduce medical expense and to improve medical access for patients with ultra rare and unknown diseases, National Health Insurance Service (NHIS, President Ki
- Policy
- Choline alfoscerates, 82 generics were approved last year
- by Lee, Tak-Sun Jan 10, 2020 06:26am
- Despite the controversy over last year's efficacy, choline alfoscerate formulations were found to have received 82 new licenses last year. Only 267 cumulative licensed items are available. On the 9th of last year, an investigation into the approved items of the same ingredient was conducted through MFDS' website. The choline alfoscerate
- Policy
- 23 new drugs approved last year with no Korean-made
- by Lee, Tak-Sun Jan 10, 2020 06:25am
- Apparently, total 23 investigational new drugs have been approved in Korea last year. Compared to 2018, the number was increased by 14 but not one of them was made in Korea. Moreover, two incrementally modified drugs (IMDs) and three biosimilars have been cleared. According to Ministry of Food and Drug Safety (MFDS)’s pharmaceutical inf
- Policy
- Ibrutinib's Asian Standard Therapy Strategy Revealed
- by Lee, Jeong-Hwan Jan 10, 2020 06:24am
- A domestic study shows that allogeneic hematopoietic stem cell transplantation is the ultimate treatment strategy for patients who do not have treatment effect after 3 months after taking Imbruvica (Ibrutinib/Janssen), a kind of hematologic cancer. The researchers also found that the initial prognostic factors of mantle cell lymphoma and t
- Policy
- Exclusive rights such as Betmiga and Olosta expire
- by Lee, Tak-Sun Jan 9, 2020 06:43am
- In 2020, the generics market is likely to be generally calm, with a small number of large-scale items whose exclusive rights expire. Nevertheless,the exclusive right of blockbuster products like hypersensitivity bladder treatment ‘Betmiga’ (Mirabegron/Astellas), hypertension-hyperlipidemia treatment ‘Duowell’(Telmisartan, Rosuvastatin/
