On September 25, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported the European Commission (EC) has granted marketing authorization to UDENYCA (formerly CHS-1701), a pegfilgrastim (Neulasta) biosimilar (Press release, Coherus Biosciences, SEP 25, 2018, View Source [SID1234531697]). UDENYCA is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe.
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"Today’s EC approval decision is the first marketing authorization for Coherus, an important step forward in realizing our mission of increasing access to biologic treatments to patients globally," said Denny Lanfear, President and CEO of Coherus BioSciences. "This decision is the result of a concerted effort across analytical, process, manufacturing and clinical/regulatory, as well as intellectual property, the pillars of our product platform. I would like to congratulate my team and our partners for their dedication and extraordinary efforts in achieving this significant milestone."
"We look forward to the anticipated US approval later this year and to executing on a vigorous launch, supported by our strategic manufacturing partners in the United States, meeting the highest product quality and production reliability standards," said Vince Anicetti, Chief Operating Officer of Coherus BioSciences.
UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date of November 3, 2018.
About UDENYCA
UDENYCA (pegfilgrastim-cbqv), formerly CHS-1701, is a growth-colony-stimulating-factor 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. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.
UDENYCA is not yet available for commercial sale.
For more information about UDENYCA contact Coherus BioSciences Medical Information at (800) 4-UDENYCA (1-800-483-3692)
Neulasta is a registered trademark of Amgen Inc.