Pfizer introduces first and only biosimilar monoclonal antibody therapy

NEW YORK - The United States Food and Drug Administration on Tuesday approved Celltrion’s Inflectra (biosimilar infliximab) across all eligible indications of the reference product, Remicade (infliximab). Inflectra is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S.

 

“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” stated Salomon Azoulay, SVP and chief medical officer, Pfizer Global Established Pharma Business. “As a leading global biologics company with several biosimilar products in our pipeline, we appreciate the significance of this milestone in developing a pathway for biosimilars to come to market in the U.S., and in helping advance their adoption in the healthcare system.”

 

Hospira, now a Pfizer company, entered into an agreement with Celltrion and Celltrion Healthcare in 2009 for several potential biosimilar products, including Inflectra. Pfizer holds exclusive commercialization rights to Inflectra in the U.S. and certain other jurisdictions.

 

Inflectra is a treatment indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and adult and pediatric Crohn’s disease.

 

The FDA approval was based on the comprehensive data package submitted by Celltrion demonstrating a high degree of similarity between Inflectra and the U.S. reference product, Remicade. The FDA’s decision follows the Feb. 9, 2016 FDA Arthritis Advisory Committee’s recommendation to approve proposed biosimilar infliximab across all eligible indications, by a vote of 21-3.

 

“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others,” noted Jenny Alltoft, head of global biosimilars, Pfizer. “Pfizer is proud to play a leading role in preparing the U.S. market for biosimilars. We are committed to bringing these important medicines to patients in the U.S. as quickly as possible. While launch timing for Inflectra will ultimately depend on a number of factors such as marketplace dynamics and intellectual property considerations, we are continuing with the preparation of our launch plans for 2016.”