Vice Provost for Academic Affairs Tony Moreira was recently appointed by the FDA to be a voting member of the FDA Arthritis Advisory Committee.
The committee met on Tuesday, February 9, 2016 to discuss the biologics license application submitted by Celltrion Inc. for their product CT-P13 which is a proposed biosimilar to REMICADE, a major biologic product already on the market manufactured by Janssen Biotech Inc.
If approved, this will be the first monoclonal antibody biosimilar product approved by the FDA to date and only the second biosimilar product overall approved by the FDA. Previously, Dr. Moreira was a voting member of the panel that reviewed the first biosimilar approved by the FDA.