Coherus BioSciences (CHRS) BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review
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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® (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® 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®. With annual U.S. Humira® 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.”
About Coherus BioSciencesCoherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system.
In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.
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