- Policy
- Reimbursement imminent for some anticancer drugs in KOR
- by Lee, Tak-Sun Sep 20, 2023 05:35am
- Jeperli Inj (dostarlimab, GSK) and Braftovi Cap 75mg (encorafenib, Ono), which passed the Drug Reimbursement Evaluation Committee meeting last month, are currently in drug price negotiations with the National Health Insurance Service. According to industry sources on the 19th, the National Health Insurance Service recently updated the li
- Policy
- MFDS starts review on phenylephrine after FDA advisory decis
- by Lee, Hye-Kyung Sep 19, 2023 05:42am
- With the Nonprescription Drug Advisory Committee (NDAC) concluding that the nasal decongestant ‘phenylephrine’ is not effective, Korea’s Ministry of Food and Drug Safety is also preparing to conduct its review. An MFDS official said, “We will decide on future measures after a comprehensive review, including discussion with experts,
- Policy
- Januvia generics up for insurance price cuts… 119 combinati
- by Lee, Tak-Sun Sep 19, 2023 05:41am
- Caution is required for the use of the generic versions CPP-4 inhibitor class antidiabetic drug ‘Januvia (sitagliptin, MSD)’ that have poured out into the Korean market as many are subject to price cuts due to inequality of price when they are prescribed in multiplications. According to industry sources on the 18th, HIRA recently added
- Policy
- Olumiant re-examination period extended by 35 months
- by Lee, Hye-Kyung Sep 18, 2023 05:26am
- In March of this year, the post-sales investigation (PMS) plan of Lilly Korea Olumiant, which was approved for severe circular alopecia indications in adult patients over the age of 18 from the Ministry of Food and Drug Safety in March of this year, will also be changed. According to the minutes of the meeting of the Central Pharmaceutical R
- Policy
- Super-antibiotic Tygacil reauthorized for use in Korea
- by Lee, Tak-Sun Sep 18, 2023 05:26am
- The ‘super-antibiotic’ Tygacil (Tigecycline, Pfizer Korea) received reauthorization in Korea and is expected to be able to avoid the treatment disruptions that had remained a lingering concern in the industry. Due to the lack of other drugs containing the same ingredient, there had been concerns that Tygacil’s failed renewal would cau
- Policy
- Authorization rate for No.16 is still 0%
- by Lee, Hye-Kyung Sep 18, 2023 05:26am
- While the Ministry of Food and Drug Safety recently completed the designation of 'Global Innovative Product Rapid Review (GIFT)' No. 16, there are still no items that have been approved using this system. The Ministry of Food and Drug Safety established the Global Innovative Products on Fast Track in September last year. It also contains innova
- Policy
- Celltrion receives approval for Nesina Met SR
- by Lee, Hye-Kyung Sep 15, 2023 05:33am
- Celltrion, which acquired the Asia-Pacific distribution rights for Takeda Pharmaceutical products, used them to create an improved new drug. One of the acquired products, Nesina Met SR, a type 2 diabetes treatment, received approval from the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety announced on the 14th that
- Policy
- Which P-CAB generic will come first, K-CAB or Vocinti?
- by Lee, Tak-Sun Sep 15, 2023 05:33am
- Companies have started developing generic versions of the P-CAB (potassium-competitive acid blocker) class gastroesophageal reflux disease (GERD) treatments K-CAB (tegoprazan, HK Inno.N) and Vocinti (vonoprazan, Takeda Pharmaceuticals Korea). The post-marketing surveillance (PMS) period for the original drugs, which are being targeted
- Policy
- Imfinzi recieves RSA reevals and seeks to extend reimb
- by Lee, Tak-Sun Sep 15, 2023 05:32am
- The Risk-Sharing Agreement (RSA) reevaluations for term renewal are underway for Imfinzi Inj (durvalumab, AZ), which applied for reimbursement extensions to its biliary tract cancer indication. The reevaluations are being conducted in preparation for the RSA contract renewal set for March next year. According to industry sources on t
- Policy
- Reevaluation difficult for Ildong and Abbott’s Lypsta
- by Lee, Tak-Sun Sep 14, 2023 06:40am
- There are slightly ambiguous aspects to Abbott Korea's ‘Lypsta Plus Tab,’ whose drug price was lowered on the 5th after the insurance price ceiling reevaluations. This drug was jointly developed between Abbott Kore and Ildong Pharmaceutical, and the bioequivalence test data among the clinical trial data was submitted by Abbott. Perhaps
