Members of the FDA Arthritis Advisory Committee voted positively today for the recommendation to approve the biologics license application of Celltrion’s CT-P13 biosimilar to infliximab. If approved, CT-P13 would be the first biosimilar monoclonal antibody to be approved for use in the United States.
In a 21-to-3 vote, the committee recommended CT-P13 should receive licensure as a biosimilar product for the indications for which the originator infliximab (Remicade, Janssen Biotech) is currently licensed in the United States and also be eligible for licensure for treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, adult and pediatric Crohn’s disease and adult ulcerative colitis.
“CT-P13 met criteria for biosimilarity. As a pediatric rheumatologist, I’m forced to use infliximab for a lot of non-FDA approved indications, so the more choices we have, the better,” Mara L. Becker, MD, MSCE, director of the Division of Pediatric Rheumatology at Children’s Mercy Kansas City, said.
MS, MPH, director of the University of Alabama at Birmingham Arthritis Clinical Intervention Program, said his dissent was related to the “residual uncertainties” about the indications for inflammatory bowel disease and concerns about immunogenicity, particularly in patients with Crohn’s disease.
, MD, staff clinician of the Division of Intramural Research NIAID for the NIH, also voted no, citing concerns about long-term safety.
The hearing included a large proportion of debate about whether inflammatory bowel diseases – namely Crohn’s disease and ulcerative colitis – and pediatric use should be approved as indications for the biosimilar as the candidate has not been studied as extensively as the biosimilar has been studied in RA and ankylosing spondylitis.
Much of the contention surrounded the concept of extrapolation, or comparing data from studies of the originator infliximab and studies of the biosimilar product, to be applicable to other indications. The concerns were expressed by numerous physicians and patient advocates.
Among comments following the vote, many of the panelists, including those who voted favorably, said more study of the biosimilar is required and more information is needed on long-term safety and efficacy data. – by Shirley Pulawski