Posted by Michael Wonder on 18 Feb 2021
Coherus BLA filing for adalimumab biosimilar candidate accepted by FDA for review
17 February 2021 - Coherus BioSciences announced that the United States FDA has accepted for review the 351(k) biologics license application for CHS-1420, a Humira (adalimumab) biosimilar product candidate, and has set a Biosimilar User Fee Act action date for December 2021.
If approved, Coherus plans to launch the adalimumab biosimilar in the U.S. on or after 1 July 2023, per the terms of an agreement with Humira manufacturer AbbVie.
