1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements

 
• By Sue Sutter

European Medicines Agency insisted on a stricter statistical analysis than the US FDA for demonstrating equivalence on the primary endpoint for both Coherus/BioEq’s Cimerli and Samsung Bioepis’ Byooviz; there also were differences in the regulators' preferred primary analysis population and primary endpoint interval.

EU US Cogs Flags
Biosimilar sponsors had to navigate the different preferences of the US and European regulators. • Source: Shutterstock

The developers of two biosimilars to Genentech’s macular degeneration drug Lucentis (ranibizumab) had to navigate trial design and statistical analyses recommendations that sometimes differed between the US Food and Drug Administration and the European Medicines Agency.

In the comparative clinical studies for Samsung Bioepis’s Byooviz and Coherus BioSciences/Bioeq's Cimerli, the EMA had stricter statistical expectations for

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Products