FDA Approves Inflectra, a Biosimilar to Remicade, to Treat Ulcerative Colitis and Crohn’s

FDA Approves Inflectra, a Biosimilar to Remicade, to Treat Ulcerative Colitis and Crohn’s

Celltrion announced that the U.S. Food and Drug Administration (FDA) approved Inflectra (biosimilar infliximab) for all indications of the reference product Remicade (infliximab), marketed in the country by Janssen Biotech, Inc.

Inflectra is an anti-inflammatory medicine that contains the active substance infliximab, and indicated for reducing symptoms of adult ulcerative colitis, and adult and pediatric Crohn’s disease, as well as psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, and plaque psoriasis.

“The FDA approval of INFLECTRA, just the second biosimilar to be approved in the U.S., is significant for the medical community as this therapy has conclusively demonstrated comparable safety and efficacy to the reference product, and will provide the medical community with an alternative, more affordable treatment option,” Vibeke Strand, MD, adjunct clinical professor, Division of Immunology/Rheumatology at Stanford University School of Medicine, said in a recent press release. “This approval will help to remove barriers for the many healthcare professionals and their patients where cost and access to treatment for these chronic autoimmune diseases has been a challenge.”

FDA approval was based on comprehensive data submitted by Celltrion, showing a high degree of resemblance between Inflectra and Remicade. Agency approval followed the its Arthritis Advisory Committee’s 21–3 vote of Feb. 9, 2016, approving biosimilar infliximab across all qualified clinical indications.

“As one of the first companies to navigate the biosimilar approval pathway with the FDA, we believe this approval will be an essential step in helping to clarify the application process for these critical medicines,” said HyoungKi Kim, chief executive officer, Celltrion. “Our experience with biosimilars outside the U.S. suggests that INFLECTRA provides patients with both therapeutic and financial benefits, and we hope to see the same value provided in the U.S.”

Inflectra is available as a powder to be made into a solution for infusion (drip) into a vein. It can only be obtained with a prescription, and treatment should be started and supervised by a specialized physician.

The biosimilar infliximab is currently approved in 71 countries, including Canada, Japan and throughout Europe, and will be marketed by Pfizer in the U.S.