Celltrion announced that the Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all indications for CT-P13, a biosimilar candidate of Remicade (infliximab; Janssen Biotech). 

CT-P13 is the first biosimilar monoclonal antibody (mAB) drug to be considered for FDA approval. The Committee based its recommendation (voted 21-3) on the evidence presented that compared CT-P13 to Remicade, the reference product. CT-P13 proved highly similar to Remicade with minor differences in clinically inactive components. There were no clinically meaningful differences in the safety, purity, and potency of CT-P13 vs. Remicade for its use in rheumatoid arthritis and ankylosing spondylitis. Biosimilarity for the other indications was based on extrapolation of other scientific data provided by Celltrion.

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Remicade is currently approved for the treatment of: moderately to severely active Crohn’s disease in adults and children; moderately to severely active ulcerative colitis in adults and children; moderately to severely active rheumatoid arthritis; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.

Pfizer will assume commercialization rights for CT-P13 under the proposed name, Inflectra, if approved by the FDA. The FDA’s decision is anticipated in April 2016. 

For more information visit Celltrion.com