Samsung Bioepis Obtains First Drug Approval in the U.S.

FDA approves biosimilar Renflexis across all eligible indications

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has approved Samsung Bioepis’ Renflexis (infliximab-abda), a biosimilar referencing Remicade i (infliximab), across all eligible indications. In the U.S., Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis. It is the first Samsung Bioepis product approved for marketing in the U.S.. “Sin...

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