Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements

05 Sep 2022

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

Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements

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