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.
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.
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