First Monoclonal Antibody Biosimilar Approved by FDA 

The First Monoclonal Antibody Biosimilar is Celltrion’s Inflectra (biosimilar infliximab). The FDA approved it across all eligible indications of the reference product, Janssen Biotech’s 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.

Hospira, now a Pfizer company, entered into an agreement with Celltrion 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.

Inflectra is administered by intravenous infusion and is the second biosimilar approved by the FDA after Sandoz’s ZarxioTM, which demonstrated biosimilarity to Amgen’s Neupogen (filgrastim) for the treatment of cancer and cancer-related complications.

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

According to Celltrion the company plans to drop the price roughly 20-30% below that of Remicade in the U.S.. But Pfizer will have a big say regarding the final price after discussions with Celltrion.

Remicade totaled annual worldwide sales of $6.5 billion, with $4.5 billion of that number in the U.S. Merck & Co. markets Remicade in Europe while Celltrion sells the biosimilar overseas under the brand Remsima.

Mandakini Kashyap
Mandakini is a bioscience enthusiast and loves to portray a picture of “Science” like never before. Serving as an Editor in Biotecnika she has penned down many interesting news and articles in the past and has also helped in posting just the right job for you. Follow her for more updates in the industry !!