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

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 FDA review and approval process, following Sandoz Inc.'s Zarxio...