On February 9th, the FDA’s Arthritis Advisory Committee held a hearing on CT-P13, a biosimilar to infliximab marketed internationally as Remsima or Inflectra.
Infliximab is approved to treat conditions including Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriasis (Pso), Crohn’s Disease (CD) and Ulcerative Colitis (UC). This would be the first biosimilar for a monoclonal antibody (MAb) approved by the FDA.
ASBM Chairman Harry Gewanter MD noted that many physician and patient groups have raised concerns about approving CT-P13 for IBD indications (CD and UC) based on data from RA and AS, due to different mechanisms of action.
For these reasons, Health Canada did not approve CT-P13 for UC and CD. Nevertheless, the AAC voted 21-3 to approve CT-P13 for all indications of its reference product.
Any indications for which FDA approval was based on extrapolation should be clearly identified on a biosimilar’s label, Dr. Gewanter cautioned, so that physicians can make informed decisions and can have confidence in biosimilars.