Coherus BioSciences Announces The FDA Issued Complete Response Letter For UDENYCA ONBODY Biologics License Application Solely Due To An Ongoing Review Of Inspection Findings At A Third-Party Filler; Announces Completion Of Toripalimab FDA Inspections
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Coherus BioSciences announced that the FDA issued a complete response letter for UDENYCA ONBODY Biologics License Application due to an ongoing review of inspection findings at a third-party filler. No issues with clinical efficacy, safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified. No additional clinical data or trials have been requested by the FDA. The company also announced the completion of Toripalimab FDA inspections.
September 25, 2023 | 12:33 pm
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Coherus BioSciences' UDENYCA ONBODY Biologics License Application is under review due to inspection findings at a third-party filler. No additional trials have been requested by the FDA, and no issues were identified with the product's clinical efficacy or safety.
The FDA's ongoing review of inspection findings at a third-party filler for Coherus BioSciences' UDENYCA ONBODY could potentially delay the product's approval. However, the fact that no additional trials have been requested and no issues were identified with the product's clinical efficacy or safety is a positive sign. This could potentially have a neutral impact on the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100