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US FDA’s Cimerli Review By The Numbers

 
• By Sue Sutter

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.

Drug Review Profile: Cimerli Chronology
Cimerli was the second biosimilar version of Lucentis approved in the US but the first deemed interchangeable. • Source: Shutterstock/Alamy

Elsewhere in this Drug Review Profile, the Pink Sheet examines how Coherus BioSciences, Inc. and Bioeq IP AG provided adequate scientific justification to support an interchangeability determination for Cimerli (ranibizumab-eqrn), a biosimilar to Genentech, Inc.’s macular degeneration drug Lucentis. (Also see "Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis" - Pink Sheet, 1 September, 2022.)

This Drug Review Profile also looks at the different expectations of the US Food and Drug Administration and European Medicines Agency for Lucentis biosimilar development programs, including Samsung...

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