Celltrion announced that the US 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 US, 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.

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 US-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.

Citation: FDA approves Celltrion’s Inflectra (biosimilar infliximab) for all indications. [news release]. Incheon, Republic of Korea; Celltrion; April 5, 2016. http://www.celltrion.com/en/company/notice_view.asp?idx=494&code=ennews&intNowPage=1&menu_num=&align_year=all. Accessed April 7, 2016.