FDA Approves Remicade Biosimilar

April 6, 2016

More than a year after approving its first biosimilar, FDA has authorized a second therapy in this category.

More than a year after approving its first biosimilar, FDA has authorized a second therapy in this category and the first monoclonal antibody (mAb) biosimilar in the U.S., Inflectra, (infliximab-dyyb), biosimilar to Janssen Biotech’s Remicade (infliximab). Inflectra is manufactured by Celltrion of Incheon, Republic of Korea, for Hospira, now part of Pfizer, which will market the product in the U.S.

The approval covers all six approved indications for Remicade, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and severe plaque psoriasis, as recommended by an FDA advisory committee at its meeting February 10. This Celltrion therapy was approved in Europe in 2013 as Remsima and is currently marketed in 67 countries, including Canada and Japan. The reference product, Remicade, was initially licensed in the U.S. in 1998 and has a long history of effectiveness for a range of  autoimmune diseases.

FDA noted that Inflectra is not approved as an interchangeable product, which may limit prescribing and dispensing. Its approval is based on extensive evidence, including structural and functional characterization data, animal studies, clinical immunogenicity data and other studies demonstrating its biosimilarity to Remicade. The product will carry a Boxed Warning to alert health professionals and patients of the risk of serious infections and side effects.

The Inflectra approval is important for FDA, which has been under pressure from Congress and the health care community to move faster to bring more affordable biosimilars to market. The agency noted in its announcement on Inflectra that biosimilars must have the same mechanism of action, route of administration, dosage form and strength as does the reference product and can be approved only for similar indications.

Inflectra’s biosimilar name carries a meaningless suffix (dyyb), as specified by FDA. Its labeling format and specifics fit FDA’s recent draft guidance on biosimilar labeling, which is generating considerable comment from all sides. Generics makers generally are pleased with the proposed policy, as it permits biosimilar labeling to be similar to that of the innovator product.