FDA approves Inflectra, the second U.S. biosimilar

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Pfizer holds exclusive rights to product in United States

WASHINGTON — Just over a year after approving its first biosimilar product, the Food and Drug Administration has approved its second, Celltrion’s Inflectra (biosimilar infliximab).

Inflectra is a biosimilar to Janssen Biotech’s Remicade (infliximab), originally licensed in 1998. Inflectra is 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 first FDA-approved biosimilar was Zarxio (filgrastim), a cancer treatment from Sandoz Inc. The product is a biosimilar to Neupogen, an oncology medication from Amgen Inc.

“Biosimilars can provide access to important treatment options for patients who need them,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said when the FDA announced the Inflectra approval. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”

Hospira entered into an agreement with Celltrion and Celltrion Healthcare Co. Ltd. in 2009 for several potential biosimilar products, including Inflectra. Last year, Hospira was acquired by Pfizer Inc., which now holds exclusive commercialization rights to Inflectra in the United States.

“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” said Salomon Azoulay, senior vice president and chief medical officer for the 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 health care system.”

Pfizer noted that the FDA’s approval was based on comprehensive data submitted by Celltrion showing a high degree of similarity between Inflectra and Remicade, the U.S. reference product.

The decision follows the Feb. 9 FDA Arthritis Advisory Committee’s recommendation to approve proposed biosimilar infliximab across all eligible indications, by a vote of 21-3, Pfizer added.

“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others,” commented Jenny Alltoft, head of global biosimilars at Pfizer Inc. “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.”



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