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 (filgrastim-sndz)
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?