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April 08, 2016 Practice Points

FDA Approves Second-Ever Biosimilar

Celltrion's Inflectra is a copy of Janssen Biotech's Remicade.

By Eric W. Shannon

On April 5, the U.S. Food and Drug Administration (FDA) approved Celltrion’s biosimilar Inflectra, a copy of Janssen Biotech's Remicade. Inflectra is now the second biosimilar to be cleared in the United States. The drug, which will eventually be marketed by Pfizer Inc, replicates Remicade’s complex monoclonal antibody structure and functions as an immunosuppressant.

According to Law360,

The FDA cleared Inflectra in every Remicade indication not covered by market exclusivity. The indications include adult and pediatric forms of Crohn’s disease, adult forms of psoriasis and ulcerative colitis, and forms of rheumatoid arthritis, psoriatic arthritis and a spinal disorder called ankylosing spondylitis. Inflectra was only studied in a subset of those indications, but the FDA extrapolated the findings to assume safety and effectiveness for other conditions.

Under a naming convention for biologics, Inflectra’s active ingredient will have a random four-letter suffix. The IV-administered drug will be sold as Inflectra (infliximab-dyyb). The product will not be made immediately available, however, due to ongoing litigation in federal court between Celltrion and Janssen, a unit of Johnson & Johnson.

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

Novartis was the first developer to gain FDA approval of a biosimilar. The agency approved Zarxio, a biosimilar of Amgen's Neupogen, in late 2015. Zarxio launched with a 15 percent discount off the price of its innovator counterpart.


Eric W. Shannon is with Debevoise & Plimpton LLP in New York, New York.

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