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FDA Approves INFLECTRA™ (Biosimilar Infliximab), The First U.S. Biosimilar Monoclonal Antibody, For All Eligible Indications

NEW YORK--(BUSINESS WIRE)--The United States (U.S.) Food and Drug Administration (FDA) today approved Celltrion’s INFLECTRA™ (biosimilar infliximab) across all eligible indications of the reference product, Remicade® (infliximab).1 INFLECTRA is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S.

“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others”

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

“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” said Salomon Azoulay, MD, senior vice president 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.”

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 February 9, 2016 FDA...