BREAKING NEWS: FDA Approves Samsung Bioepis’s Biosimilar of REMICADE®

Approved Biosimilar Products  •  U.S. FDA News

Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®.  According to the approved prescribing information, RENFLEXIS® is indicated for the treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis (in adult patients), rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.  REMICADE®, in contrast, is additionally indicated for the treatment of pediatric ulcerative colitis.

RENFLEXIS® is the second biosimilar of REMICADE® to receive FDA approval, the first being Celltrion’s and Hospira’s Inflectra®, which launched in the United States late last year.  RENFLEXIS® is just the fifth biosimilar product overall to receive FDA approval under the BPCIA scheme, and the first since Amgen’s AMJEVITA® (adalimumab-atto) in September last year.

Stay tuned to Big Molecule Watch for further developments.

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