FDA Arthritis Advisory Committee recommends CTP 13 (infliximab biosimilar) for all indications of the reference product - Hospira/Pfizer

The FDA Arthritis Advisory Committee has approved the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three. Celltrion's proposed biosimilar infliximab, to which Pfizer/Hospira holds exclusive U.S. commercialization rights, is the first biosimilar monoclonal antibody (mAb) therapy to be reviewed by the FDA for licensure in the U.S., and is only the second biosimilar to be recommended for approval by a U.S. FDA Advisory Committee.

The FDA is considering the proposed biosimilar infliximab for all indications of the reference product eligible for licensure, including the treatment of rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.

Comment: Hospira, now a Pfizer company, entered into a business cooperation agreement with Celltrion in 2009 for several biosimilar products, including a potential biosimilar to Remicade (infliximab). Pfizer has exclusive commercialization rights to the proposed biosimilar infliximab in the U.S. and certain other jurisdictions.The biosimilar was approved in the EU in September 2013, and has been launched (as Inflectra or Remsima) in many markets.