Benzinga | Feb 17, 2021 07:31AM EST

Coherus' Biologics License Application Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review

Coherus BioSciences, Inc. (Nasdaq: "CHRS", "the Company", "Coherus") announced that the United States Food and Drug Administration ("FDA") has accepted for review the 351(k) Biologics License Application ("BLA") for CHS-1420, a Humira(r) (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 July 1, 2023, per the terms of an agreement with Humira(r) manufacturer AbbVie.

"We are pleased to see the CHS-1420 BLA accepted for review as we continue to execute on our mission to increase patient access to important medicines and deliver substantial savings to the healthcare system," said Denny Lanfear, CEO of Coherus. "Our market research indicates that there is substantial pent-up demand for biosimilars of Humira(r). With annual U.S. Humira(r) sales projected to exceed $18 billion by the time of our planned launch, the adalimumab market is by far the largest opportunity in our biosimilar pipeline. We plan to be a top competitor and expect to earn significant sales of CHS-1420, growing and diversifying the biosimilar portfolio revenues funding our expansion into immuno-oncology."