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Samsung Bioepis Scoops First EU Lucentis Biosimilar As 2022 Date Looms

Byooviz Biosimilar Backed By EMA Committee In June

Executive Summary

Samsung Bioepis has seen a positive opinion in the EU for its Byooviz (ranibizumab) biosimilar treatment for wet age-related macular degeneration turned into final approval by the European Commission. The company is also leading the pack in the US.

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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.

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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