US FDA’s Byooviz Review By The Numbers
Executive Summary
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.
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US FDA’s Cimerli Review By The Numbers
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.
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.
Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis
Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.