FDA approves Celltrion's Inflectra as biosimilar version of Remicade

The FDA on Tuesday approved Celltrion's Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson's and Merck & Co.'s Remicade (infliximab), which will be marketed in the US by Pfizer, for the treatment of several indications including rheumatoid arthritis. The approval of Inflectra marks the first authorisation of a biosimilar of Remicade in the US and the second approval of any biosimilar in the country, following the clearance of Novartis' Zarxio last year.

In February, an FDA advisory panel voted 21 to 3 backing approval of Inflectra for all indications for which Remicade is currently approved. In documents released ahead of an advisory panel meeting, FDA staff concluded that the biosimilar was "highly similar" to Remicade.

Celltrion developed Inflectra under the terms of an agreement forged with Hospira in 2009, with Pfizer obtaining rights to the therapy following its acquisition of the latter drugmaker last year.

For related analysis, see ViewPoints: The long wait is over for US approval of a complex biosimilar, though more delays ahead.

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