Inflectra Analytical Data Eased FDA's 'Residual Uncertainty' About Remicade Differences

Jul 15 2016

• By Sue Sutter

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Pink Sheet's Drug Review Profile reveals FDA's second biosimilar got hung up on product quality concerns that suggested potential differences between Celltrion's CT-P13 and its reference biologic, Janssen's infliximab.

The US regulatory review of Celltrion Inc.'s Inflectra, a biosimilar of Janssen Biotech Inc.'s Remicade, was waylaid by residual uncertainties about potential product quality differences that required additional analytical similarity data – and a second review cycle – before FDA was sufficiently confident that the product was highly similar to its reference biologic.

Inflectra (infliximab-dyyb, also known as CT-P13) was only the second biosimilar application to make it all the way through the...

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