The developers of two biosimilars to Genentech, Inc.’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.
Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements
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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