OREANDA-NEWS. February 11, 2016.  Pfizer Inc. commends today’s recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve 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 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.

“As a leading global biosimilars company and having seen firsthand the impact of biosimilars in other countries during the past eight years, we applaud the FDA Advisory Committee for reaching this positive recommendation," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development, Global Established Pharma, Pfizer Inc. “Biosimilars represent an exciting opportunity to expand patient access to important treatments, and we are proud to be at the forefront of helping shape and prepare the U.S. market for these therapies.”

The Advisory Committee’s recommendation to approve the proposed biosimilar infliximab for all eligible indications, based on extrapolation of data, marks a critical next step in helping create a sustainable market for biosimilars in the U.S. Pfizer recognizes the importance of this milestone in more broadly advancing opportunities to expand patient access to high-quality, lower-cost alternative treatment options through biosimilars.

The FDA is not bound by the Advisory Committee’s recommendation, but the Agency takes its advice into consideration when reviewing the biologics license application (BLA) for medicinal products.

“We look forward to the FDA’s continued review and, while awaiting its decision and certain other factors, we are moving ahead with the preparation of our launch plans for 2016,” said Jenny Alltoft, global biosimilars lead, Pfizer Inc. “Pfizer remains committed to bringing these important medicines to patients in the U.S. as quickly as possible.”

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).1 Pfizer has exclusive commercialization rights to the proposed biosimilar infliximab in the U.S. and certain other jurisdictions.

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1 Remicade® is a registered U.S. trademark of Janssen Biotech, Inc.