FDA approves Celltrion’s INFLECTRA™ (Biosimilar Infliximab) for all indications
Celltrion, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved INFLECTRA™ (biosimilar infliximab, sold in Europe as Remsima®) for all indications of the reference product, Janssen Biotech Inc.'s Remicade® (infliximab). INFLECTRA is the first biosimilar monoclonal antibody (mAb) medication to receive approval in the U.S., and is indicated for the treatment of patients with a number of serious autoimmune diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
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The FDA based its approval on the totality of evidence presented at the Arthritis Advisory Committee meeting on February 9, 2016, demonstrating no clinically meaningful differences between INFLECTRA and U.S.-licensed Remicade® in terms of the safety, purity, and potency of the product. Following a discussion among the Advisory Committee, the panel recommended FDA approval of INFLECTRA across all eligible indications by a vote of 21-3.
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INFLECTRA is currently approved in 71 countries across the globe and will be commercialized by Pfizer in the United States.