Samsung Bioepis' Renflexis, a biosimilar of Remicade, approved in Sth Korea
South Korean drug developer Samsung Bioepis, a joint venture between Korean conglomerate Samsung and US biotech Biogen (Nasdaq: BIIB), received approval of Renflexis (infliximab), a biosimilar of Merck’s immunology medicine Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea.
US pharma giant Merck & Co (NYSE: MRK) will commercialize Renflexis in Korea as part of Merck’s commercialization partnership with Samsung Bioepis to offer high-quality biosimilar alternatives to existing biologic medicines.
Renflexis is indicated in Korea for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis in adult patients (age 18 years and older). Merck plans to launch Renflexis in South Korea in the first half of 2016.
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