- Policy
- Remote GMP inspections not recognized from April
- by Lee, Hye-Kyung Jan 29, 2024 06:05am
- The GMP inspections, which were temporarily allowed non-face-to-face due to the difficulty of on-site evaluations during the COVID-19 outbreak, are gradually returning to ordinary procedures. After switching the pre-approval GMP item inspections back to full on-site inspections in December last year, the Ministry of Food and Drug Safety (
- Policy
- Lilly’s UC drug Omvoh is soon to be approved in KOR
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- Lilly's ulcerative colitis treatment Omvoh (mirikizumab-mrkz) is nearing approval in Korea. Omvoh received U.S. FDA approval in October last year and settled as the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. According to industry sources,
- Policy
- P2T for LG Chem’s obesity drug LB54640 approved in Korea
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- LG Chem’s generic obesity treatment, 'LB54640,' has been approved for a Phase II clinical trial in Korea. On the 24th, the Ministry of Food and Drug Safety approved LG Chem’s application to initiate a randomized, placebo-controlled, double-blind Phase II study with an open extension period to evaluate the efficacy and safety of LB54640
- Policy
- MOHW “Drug pricing for listed drugs is set to be reduced"
- by Lee, Jeong-Hwan Jan 26, 2024 05:50am
- In February, the government will post the outcomes of notifications of the second-round review & assessment, analyzing the upper limit of standards and requirements associated with the drug pricing reduction of currently listed generics. The adjusted prices will take effect on March 1st. The drug pricing reduction related to market-bas
- Policy
- Chong Kun Dang cuts price of its Lucen BS by half
- by Lee, Tak-Sun Jan 25, 2024 05:50am
- Chong Kun Dang is offering a bargain price for its biosimilar. The company has decided to cut the price of its 'Lucen BS', a biosimilar of the macular degeneration treatment Lucentis (ranibizumab, Novartis), by half from next month. As a result, the price difference between it and the original product, as well as it and Samsung Bioepis
- Policy
- Handok-Sanofi launches hypertension combo drug Aprovasc
- by Lee, Tak-Sun Jan 24, 2024 05:45am
- Aprovasc, a hypertension combination drug co-developed by Handok and Sanofi Aventis Korea, will enter the market in earnest with reimbursement on the 1st of next month. The product is a combination drug of ARB-class irbesartan, which was developed by Sanofi, and CCB-class amlodipine besylate. This is the first irbesartan-amlodipine combin
- Policy
- New drug Zavicefta Inj, and more completed drug pricing nego
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- The two drugs Pfizer Korea’s ‘Zavicefta Inj’ and ‘Dulackhan Easy Syrup,’ which were in negotiations for a drug pricing increase due to short supply, have reached agreements in negotiations with the National Health Insurance Service (NHIS), and they are expected to receive reimbursements starting next year. The chronic kidney diseas
- Policy
- Samsung Bioepis receives approval for its Soliris biosimilar
- by Lee, Hye-Kyung Jan 23, 2024 06:02am
- Samsung Bioepis has received approval for its Epysqli (eculizumab),’ a biosimilar of the ultra-high-priced rare disease treatment Soliris (eculizumab) in Korea. At the same time, it was granted first generic exclusivity until October 19th of this year, allowing Samsung Bioepis to market its biosimilar exclusively for the next nine months
- Policy
- Korean patients pay ₩10.5M for ₩300M Luxturna
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- Luxturna (voretigene neparvovec-rzyl, Novartis), the first gene therapy for Inherited Retinal Dystrophy (IRD), is set to be reimbursed from the 1st of next month and is expected to significantly reduce the burden of those suffering from IRD in Korea. Although the price limit for Luxturna had been set at KRW 325.8 million per vial, the out
- Policy
- Luxturna, Kerendia, & Raspirin will get new reimb standards
- by Lee, Jeong-Hwan Jan 22, 2024 05:49am
- New reimbursement standards will be established for Novartis’s Luxturna, a one-shot retinal dystrophy treatment, Hanmi Pharmaceutical’s Raspirin Cap, and Bayer’s Kerendia Tab 10 mg, as they are set to be listed for reimbursement. Reimbursement standards will be set for Takeda’s Obizur, a treatment for acquired hemophilia A, and Pfiz
