Results Wire: US FDA Advisory Committee Supports Celltrion’s Proposed Biosimilar to Remicade– FEB 9, 2016 (AAC)
On February 9, 2016, the Arthritis Advisory Committee (AAC) voted in support, by a vote of 21-Yes to 3-No, with no abstentions, of the licensure of Celltrion Inc’s CT-P13 as a biosimilar product to Remicade (infliximab) for each of the indications for which Remicade is currently licensed:
Rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), plaque psoriasis (PsO), ulcerative colitis (UC), and adult and pediatric Crohn’s disease (CD). The FDA is expected to issue its decision by April 6, 2016. If approved, Pfizer will commercialize CT-P13 in the U.S. under the proposed trade name Inflectra.
See the SAC Tracker report