Benzinga | Oct 1, 2021 01:11PM EDT

Coherus Announces BLA Filing For Lucentis (ranibizumab) Biosimilar Candidate Accepted By FDA For Review

Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced the United States Food and Drug Administration (FDA) has accepted for review the 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar candidate of reference product Lucentis(r) (ranibizumab). The FDA has set a Biosimilar User Fee Act action date for August 2, 2022, and, if approved, Coherus plans to launch the Lucentis biosimilar in the U.S. in the second half of 2022. The BLA for CHS-201 (also known as FYB201) was submitted by Coherus' partner, Bioeq AG, from whom Coherus acquired U.S. commercial rights in 2019.

"We are gratified that the CHS-201 BLA was accepted for review as it represents yet another milestone on our mission to expand access to important medicines while delivering substantial savings to the U.S. health care system," said Denny Lanfear, CEO for Coherus. "We have a demonstrated track record of successful biosimilar commercialization, and we plan to leverage that same expertise in the ophthalmology setting. We look forward to supporting our partners at Bioeq during the review process."

In addition to CHS-201, Coherus' biosimilar portfolio includes UDENYCA(r) (pegfilgrastim-cbqv), which the Company launched in the United States in January 2019; CHS-1420, a biosimilar candidate of reference product Humira(r) (adalimumab), currently under review by the FDA with a target action date of December 2021; and CHS-305, a biosimilar candidate of reference product Avastin(r) (bevacizumab), currently being evaluated in a comparative pharmacokinetic study in healthy subjects to support a potential BLA filing in 2022.