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Coherus BioSciences Announces Filing of Patent Infringement Suit Against Amgen Directed to Amgen’s Humira Biosimilar Formulation
“Coherus recognized early on the central role intellectual property would play in advancing biosimilars to market,” said
Coherus’ Humira® biosimilar candidate, CHS-1420, is among a number of significant biosimilar candidates in Coherus’ pipeline of high-value treatments for patients in need, including biosimilar candidates directed to Enbrel®, Lucentis®, and Eylea®.
Coherus is currently preparing its biologics license application for CHS-1420 for submission to the U.S. Food and Drug Administration, with anticipated filing in late 2019. Upon the expected U.S. market launch of CHS-1420 in late 2023, the company believes it will be well-positioned to effectively leverage the commercial infrastructure it has already deployed for its recent U.S. launch of UDENYCA™ (pegfilgrastim-cbqv). The company continues to evaluate options and potential strategies for ex-U.S. commercialization of CHS-1420.
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 the timing of the filings of the biologics license application for CHS-1420 and approvability of CHS-1420; Coherus’ expectations regarding the timing of the U.S. commercial launch of CHS-1420 and its ability to leverage its commercial infrastructure for such commercial launch; Coherus’ expectation to continue the development of its biosimilars in anti-inflammatory and ophthalmology therapeutic areas; Coherus’ expectations regarding the value to patients of Coherus’ products in development; and Coherus’ ability to enforce its intellectual property for CHS-1420. 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. Such risks and uncertainties include, among others, whether our commercial launch of UDENYCA™ will be successful and generate meaningful sales; the risk that our current available cash will be sufficient to fund our planned expenditures and meet our obligations; the risk and uncertainty inherent in being able to secure financing, either by incurring additional debt or from the sale of our equity, in sufficient amounts or on acceptable terms; the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings such as the biologics license application for CHS-1420; the risk that CHS-1420 will not be approved prior to the anticipated U.S. market launch on
UDENYCA™ is a trademark of
Enbrel® is a registered trademark of
Humira® is a registered trademark of
Lucentis® is a registered trademark of
Eylea® is a registered trademark of
Vice President, Investor Relations & Corporate Affairs
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Source: Coherus BioSciences, Inc.