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.