Celltrion announced that Inflectra (biosimilar infliximab) has been approved by the U.S. Food and Drug Administration (FDA) for all the same indications that Remicade (infliximab) is approved, including rheumatoid arthritis (RA), making the drug the first and only biosimilar monoclonal antibody (mAb) therapy to be approved in the United States.
Hospira, which is now part of Pfizer, established an agreement with Celltrion in 2009 for a series of potential biosimilar products, including Inflectra. Pfizer now owns the exclusive rights for the commercialization of the drug in the U.S. and several other areas.
“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” said Salomon Azoulay, M.D., senior vice president and CMO of Pfizer Global Established Pharma Business, in a press release. “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.”
The FDA approval was based on the data package submitted by Celltrion, which had to demonstrate a high degree of similarity between Inflectra and its reference product, Remicade. The agency’s decision follows an Arthritis Advisory Committee’s recommendation issued Feb. 9 approving the proposed biosimilar infliximab for all eligible indications. The recommendation had three votes against it, but the majority of the committee supported it.
Besides rheumatoid arthritis, Inflectra is indicated for reducing signs and symptoms in patients with Crohn’s disease, adult ulcerative colitis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.
“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians, and others,” said Pfizer’s head of Global Biosimilars, Jenny Alltoft. “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.”
More information about the European Medicines Agency (EMA)’s assessment report of Inflectra (biosimilar infliximab) is available here.