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.
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.
INFLECTRA is currently approved in 71 countries across the globe and will be commercialized by Pfizer in the United States.
