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US FDA’s Byooviz Review By The Numbers

 
• By Sue Sutter

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.

Drug Review Profile: Byooviz Chronology
Byooviz was the first biosimilar to Lucentis approved in the US. • Source: Shutterstock/Alamy

Elsewhere in this Drug Review Profile, the Pink Sheet examines how Samsung Bioepis Co., Ltd. and Coherus BioSciences, Inc./Bioeq IP AG, sponsors of biosimilar versions of Genentech, Inc.’s macular degeneration drug Lucentis, had to navigate different expectations from the US Food and Drug Administration and European Medicines Agency. (Also see "Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements" - Pink Sheet, 1 September, 2022.)

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