FDA Staff Backs Remicade Biosimilar

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FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.

The agency made the announcement ahead of a Feb. 9, 2016 panel meeting. The panel will decide whether to recommend FDA approval of Celltrion’s biosimilar for the treatment of rheumatoid arthritis and inflammatory bowel diseases.

As a result of the announcement, J&J’s stocks fell nearly 4%. Shares of both Amgen and AbbVie, who also market arthritis biosimilars, dropped 3% and 6%, respectively. Pfizer, who has partnered with Celltrion to market the biosimilar, saw a 1% increase in shares.


The National Health Institute for Health and Care Excellence (NICE) announced in January 2016 that the organization plans to back Remicade biosimilars in Europe. Merck markets Remicade in Europe, and during a Q4 call, executives said that the company’s market share for Remicade has decreased 5% (from 90% to 85%) from third to fourth quarter. The company also said they expect biosimilar makers to focus on securing new users of the drugs as the market expands.

Source: Reuters