The U.S. Food and Drug Administration (FDA) this week approved Celltrion’s INFLECTRA (biosimilar infliximab) for all qualified indications of the reference product, Remicade (infliximab).
With the approval, INFLECTRA becomes the first and only currently approved biosimilar monoclonal antibody (mAB) therapy in the United States.
Pfizer subsidiary, Hospira, began a partnership with Celltrion Inc. and Celltrion Healthcare Co., Ltd. In 2009 to begin development on several potential biosimilar products, which included INFLECTRA. The exclusive U.S. commercialization rights for INFLECTRA belong to Pfizer.
INFLECTRA was designed to reduce the signs and symptoms of rheumatoid arthritis in patients, as well as ulcerative colitis in adults, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease in adults and pediatrics.
The approval of INFLECTRA came after a comprehensive data package was submitted to the FDA by Celltrion. The data confirmed similarities between INFLECTRA and Remicade, INFLECTRA’s U.S. reference product. The FDA’s decision to approve the product came after the FDA Arthritis Advisory Committee’s recommendation.
The committee voted 21-3 to recommend the potential drug across all eligible indications on Feb. 9.