FDA Calendar

Company Name Coherus Biosciences, Inc.
Drug Name CHS-201 (BLA)
Event Name FDA decision on CHS-201, a biosimilar candidate of Lucentis
Event Date 08/02/2022
Outcome Date 08/03/2022
Outcome FDA approved CIMERLI, formerly CHS-201, as a biosimilar product interchangeable with Lucentis on Aug.3, 2022
Drug Status
Rival Drugs Samsung Bioepis Co/Biogen's Byooviz approved on Sep.21, 2021, is the first approved biosimilar to Lucentis.

Lucentis, co-commercialised by Roche and Novartis, is approved for Macular Edema, Diabetic Macular Edema, Macular Degeneration, Diabetic Retinopathy, and Myopic Choroidal Neovascularization
Market Potential Lucentis annual sales in U.S. totaled $1.46 billion in 2021
Other Approvals
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