FDA Approves Rheumatoid Arthritis Biosimilar

By Maria Armental 

U.S. health regulators have approved for sale Pfizer Inc.'s lower-priced "biosimilar" version of Remicade, a Johnson & Johnson and Merck & Co. treatment for rheumatoid arthritis.

Inflectra -- which Pfizer Inc. acquired as part of its merger with Hospira -- is already approved for sale in Canada, Mexico, Australia and parts of Europe.

It is the second "biosimilar" approved for sale in the U.S., following last year's Food and Drug Administration approval of Novartis AG's Zarxio , a rival version of Amgen Inc.'s Neupogren.

Biosimilars, derived from living organisms, are approved based on a showing that they are highly similar to an already approved biological product and that they have no clinically meaningful safety and effectiveness differences from the originally approved product, according to the FDA.

In the U.S., Inflectra will have a boxed warning of higher risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis and invasive fungal infections, the FDA said.

Inflectra is made by South Korea's Celltrion Inc.

Pfizer's stock, up 2% during regular trading, rose 0.6% to $31.55 after hours.

Write to Maria Armental at [e-mail]

(END) Dow Jones Newswires

April 05, 2016 17:27 ET (21:27 GMT)

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