Coherus BioSciences Receives European Commission Approval for UDENYCA™ (Pegfilgrastim Biosimilar)
- Category: Proteins and Peptides
- Published on Wednesday, 26 September 2018 10:28
- Hits: 625
REDWOOD CITY, CA, USA I September 25, 2018 I Coherus BioSciences, Inc. (Nasdaq: CHRS), today announced the European Commission (EC) has granted marketing authorization to UDENYCA™ (formerly CHS-1701), a pegfilgrastim (Neulasta®) biosimilar. UDENYCA™ is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe.
"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.
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.
About Coherus BioSciences, Inc.
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), and CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
SOURCE: Coherus BioSciences