Coherus Reports the US FDA's Acceptance of BLA for CHS-201 (biosimilar, ranibizumab)
Shots:
- The US FDA has accepted the BLA under the 351(k) for CHS-201 (biosimilar, ranibizumab) with an anticipated BsUFA date is Aug 02, 2022
- If approved, the company plans to launch the Lucentis biosimilar in the US in H2'22
- Additionally, Coherus' biosimilar portfolio includes Udenyca which has launched in the US in Jan'19 while CHS-1420 (biosimilar, adalimumab) is currently under FDA's review with anticipated PDUFA date on Dec'21 & CHS-305 (biosimilar, bevacizumab) is currently being evaluated in PK study to support a BLA submission in 2022
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