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...
FDA's review documents pull back the curtain on the key issues that led to this regulatory action.