Trials & Filings

Samsung Bioepis’ RENFLEXIS Wins Approval in Korea

Biosimilar to J&J’s Remicade shows comparable safety and efficacy in Phase III trials

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By: Kristin Brooks

Managing Editor, Contract Pharma

Samsung Bioepis has received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for RENFLEXIS, a biosimilar version of J&J’s Remicade (infliximab), for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This marks the company’s second regulatory approval in Korea; BRENZYS, a biosimilar version of Amgen’s Enbrel (etanercept), was approv...

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