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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A timeline of the development and approval of Coherus’ Cimerli, the first interchangeable biosimilar to Genentech’s macular degeneration drug Lucentis, and a listing of FDA staff involved in the review.
A timeline of the development and approval of Samsung Bioepis’ Byooviz, a biosimilar to Genentech’s Lucentis, and a listing of FDA reviewers on the biologics license application.
Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.