On July 27, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS), reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of UDENYCA (formerly CHS-1701), a pegfilgrastim (Neulasta1) biosimilar candidate (Press release, Coherus Biosciences, JUL 27, 2018, View Source [SID1234531701]). UDENYCA has the opportunity to become one of the first pegfilgrastim biosimilars to gain Marketing Authorization in Europe.
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"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 Denny Lanfear, President and CEO of Coherus BioSciences. "We believe UDENYCA will represent an important option for patients, providers and payers seeking alternatives for the treatment and prevention of febrile neutropenia due to cytotoxic chemotherapy in Europe."
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 Barbara Finck, M.D., Chief Medical Officer of Coherus BioSciences. "We have worked in a harmonized fashion with the EU and U.S. regulatory authorities, and continue to work with the FDA toward our expected November action date."
The European Commission decision on the approval for UDENYCA is expected in October. UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date expected on or before November 3, 2018.
1 Neulasta is a registered trademark of Amgen Inc.
About UDENYCA
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 $4.5 billion in 2017. UDENYCA drug substance manufacturing is located in Boulder, Colorado.