On April 5th, the FDA approved Inflectra (infliximab-dyyb), making it the second biosimilar approved for sale in the U.S.
Notably, Inflectra was approved for all the indications of its reference product for which it applied, including Rheumatoid Arthritis (RA) Ankylosing Spondylitis (AS), and IBD indications such as Ulecerative Colitis (UC) and Crohn’s Disease (CD). Inflectra did not apply for, and was not approved for Pediatric UC.
Physicians and patient groups raised concerns following the European Medicines Agency’s 2013 approval of Inflectra for IBD indications without clinical data demonstrating similar safety and efficacy to the originator medicine in those indications. By contrast, in 2014, Health Canada approved Inflectra for treating RA and AS, but not did approve for IBD indications. Read the FDA’s press release on the approval here.
ASBM’s Chairman Dr. Harry L. Gewanter testified at the Feb. 9th Arthritis FDA Advisory Committee Hearing on Inflectra. ASBM’s testimony may be read here.