FDA approves Inflectra (biosimilar infliximab) for all Remicade (infliximab) indications- Pfizer

The FDA has approved Celltrion’s Inflectra (biosimilar infliximab) across all eligible indications of the reference product, Remicade (infliximab). Inflectra is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S.

Hospira, now a Pfizer company, entered into an agreement with Celltrion Inc. and Celltrion Healthcare, Co., Ltd. in 2009 for several potential biosimilar products, including Inflectra. Pfizer holds exclusive commercialization rights to Inflectra in the U.S. and certain other jurisdictions. Inflectra is a treatment indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.

The FDA approval was based on the comprehensive data package submitted by Celltrion demonstrating a high degree of similarity between Inflectra and the U.S. reference product, Remicade. The FDA’s decision follows the February 9, 2016 FDA Arthritis Advisory Committee’s recommendation to approve proposed biosimilar infliximab across all eligible indications, by a vote of 21-3.

Comment: The Remicade patent in the US is due to expire in September 2018. Janssen have filed a complaint at the US District Court for the District of Massachusetts, alleging Celltrion failed to follow the Biologics Price Competition and Innovation Act and breached 6 patents of Janssen.