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Coherus BioSciences Receives Positive CHMP Opinion for UDENYCA™ (Pegfilgrastim Biosimilar Candidate)
"The positive opinion issued by the CHMP today is a significant milestone for Coherus, as it validates both our UDENYCA biosimilarity package as well as our development platform as a whole,” said
UDENYCA’s marketing authorization application to EMA is supported by analytical similarity data, a 3-arm, triple-crossover pharmacokinetic (PK) and pharmacodynamics (PD) study in healthy subjects, as well as a robust immunogenicity package including a dedicated immunogenicity study in over 300 subjects.
“UDENYCA is clinically differentiated with positive PK/PD and immunogenicity studies in over 600 healthy subjects,” said
1 Neulasta® is a registered trademark of
UDENYCA™, formerly CHS-1701, is a biosimilar candidate to pegfilgrastim, a growth-colony-stimulating-factor (G-CSF) designed to decrease the chance of infection as manifested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of
Coherus is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales & marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, UDENYCA™ (pegfilgrastim biosimilar), CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), as well as developing a robust pipeline of future products in ophthalmology (including CHS-3351, a ranibizumab biosimilar, and CHS-2020, an aflibercept biosimilar), as well as CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to receive approval for UDENYCA from the
Jean-Frédéric Viret, Ph.D.
Chief Financial Officer
+1 (650) 649-3546