Redwood City, CA (GLOBE NEWSWIRE) - Coherus BioSciences, Inc. (“Coherus” or “the Company,” Nasdaq: CHRS), is pleased to announce that it has produced over 400,000 UDENYCA® pre-filled syringes to date.
The cumulative production of 400,000 UDENYCA® pre-filled syringes is a significant milestone, as it represents approximately one-third of the annual utilization of pegfilgrastim in the United States.
“Coherus provides unencumbered choice of pegfilgrastim product to patients and providers in the United States," said Denny Lanfear, President and CEO of Coherus. “Choice improves access and puts biosimilars squarely on the front line in the fight to restrict and reverse unsustainable biologic price growth.”
July 4th is the six-month anniversary of UDENYCA®'s launch and first availability in the United States. UDENYCA® is proudly made in America, with manufacturing located in Boulder, Colorado, and the entire fill-and-finish supply chain located within the continental United States. All facilities have successfully completed multiple FDA (US Food and Drug Administration) and EMA (European Medicines Agency) inspections.
Coherus estimates that over 200 American jobs are directly attributed to the production of UDENYCA®.
“I want to congratulate the Coherus Operations Team and our manufacturing partners on achieving this significant milestone,” commented Vince Anicetti, Chief Operations Officer of Coherus. “We are on track to produce sufficient pegfilgrastim to supply our one millionth UDENYCA® pre-filled syringe by early next year.”
UDENYCA® (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with 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 a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Limitations of Use
UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Important Safety Information
Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.
Warnings and Precautions
- Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
- Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA® in patients with ARDS.
- Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA® in patients with serious allergic reactions.
- Fatal sickle cell crises: Have occurred.
- Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA® if causality is likely.
Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full Prescribing Information available at www.UDENYCA.com
About Coherus BioSciences, Inc.
Coherus BioSciences 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 and marketing and clinical-regulatory development, Coherus BioSciences is positioned as a leader in the global biosimilar marketplace. Coherus BioSciences commercializes UDENYCA® (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA® in the European Union. Coherus BioSciences is advancing two late-stage clinical products towards commercialization, CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), and 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’ expectations regarding its ability to produce up to one million UDENYCA® pre-filled syringes by early 2020, to improve access to pegfilgrastim and to restrict and reverse unsustainable biologic price growth for pegfilgrastim and other biologics. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the three months ended March 31, 2019, filed with the Securities and Exchange Commission on May 9, 2019 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended March 31, 2019 are not necessarily indicative of our operating results for any future periods.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
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