FDA Strikes Off Coherus BioSciences' New Injector Biosimilar Treatment For Cancer Patients
Portfolio Pulse from Vandana Singh
The FDA has issued a Complete Response Letter to Coherus BioSciences Inc (NASDAQ:CHRS) regarding its Udenyca Onbody, an on-body injector (OBI) presentation of Udenyca, due to an ongoing review of inspection findings at a third-party filler. The CRL did not identify any issues with the Udenyca Onbody's clinical efficacy or safety. Coherus also announced that the FDA has completed the clinical study site inspections of three clinical sites in China for the toripalimab BLA. CHRS shares are down 8.74%.
September 25, 2023 | 7:35 pm
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NEUTRAL IMPACT
Amgen Inc's Neulasta, a prescription medicine used to prevent neutropenia caused by chemotherapy, is a biosimilar of Coherus BioSciences' Udenyca.
Amgen's Neulasta is mentioned as a biosimilar of Coherus BioSciences' Udenyca. However, the news does not directly impact Amgen.
CONFIDENCE 80
IMPORTANCE 50
RELEVANCE 50
NEGATIVE IMPACT
Coherus BioSciences' Udenyca Onbody is under review by the FDA due to inspection findings at a third-party filler. This has led to a drop in CHRS shares.
The FDA's ongoing review of inspection findings at a third-party filler for Coherus BioSciences' Udenyca Onbody has led to uncertainty, causing a drop in CHRS shares.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100