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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.

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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...

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