FDA Panel Gives High Marks to Remicade Biosimilar

Approval decision expected in April 2016

The FDA’s Arthritis Advisory Committee has recommended approval of all eligible indications for CT-P13 (Celltrion/Pfizer), a proposed biosimilar to Janssen Biotech’s Remicade (infliximab), by a vote of 21 to 3. CT-P13 is the first biosimilar monoclonal antibody medication to be considered by the FDA. Korea-based Celltrion is seeking approval of CT-P13 for the treatment of a variety of autoimmune diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis (RA), and ankylosing spondylitis (AS).

The FDA panel based its recommendation on clinical data comparing CT-P13 with the U.S. reference product Remicade. The committee concluded that CT-P13 is highly similar to Remicade, notwithstanding minor differences in clinically inactive components. Further, the committee noted that there were no clinically meaningful differences between CT-P13 and Remicade in terms of the safety, purity, and potency of the product in the studied indications of RA and AS.

If approved, Pfizer would assume commercialization rights for the medication in the U.S. under the proposed brand name Inflectra. The FDA’s approval decision is expected in April 2016.

Remicade has been licensed in the U.S. for 18 years and is indicated 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 RA
  • Active AS
  • Active psoriatic arthritis
  • Chronic severe plaque psoriasis

CT-P13 is currently approved in 67 countries, including Canada, Japan, and throughout Europe.

Source: Celltrion; February 10, 2016.