Coherus BioSciences Announces FDA Acceptance of 351(k) Biologics License Application to U.S. Food and Drug Administration for...
October 06 2016 - 5:53PM
Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play,
global biosimilar company with late-stage clinical
products, today announced that the U.S. FDA has accepted the
filing of 351(k) Biologics License Application for CHS-1701, a
pegfilgrastim (Neulasta®) biosimilar candidate.
The BLA submission is supported by similarity
data from analytical, pharmacokinetic, pharmacodynamic and
immunogenicity studies comparing CHS-1701 and Neulasta. The
biosimilar user fee act (BSUFA) action date is June 9, 2017.
About Coherus BioSciences, Inc. Coherus is a
leading pure-play, global 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 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, CHS-1701
(pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and
CHS-1420 (adalimumab biosimilar), as well as developing a robust
pipeline of future products in four therapeutic areas, oncology,
immunology (anti-TNF), ophthalmology and multiple sclerosis. For
additional information, please visit www.coherus.com.
Forward-Looking StatementsExcept for the
historical information contained herein, the matters set forth in
this press release, including statements regarding Coherus’ plans,
potential opportunities including market opportunities,
expectations, goals, objectives, strategies, product pipeline,
clinical studies, product development, and the potential benefits
of its products under development are forward-looking statements
within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, including Coherus’
ability to obtain marketing approval for and commercialize
CHS-1701. Such forward-looking statements involve substantial risks
and uncertainties that could cause our clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the uncertainties inherent in the clinical drug
development process, including the regulatory approval process, the
timing of our regulatory filings and other matters that could
affect the availability or commercial potential of our biosimilar
drug candidates, as well as possible patent litigation. 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 quarter ended June 30, 2016, filed with
the Securities and Exchange Commission on August 9, 2016 and its
future periodic reports to be filed with the Securities and
Exchange Commission.
Neulasta® is a registered trademark of Amgen
Inc.
Contact:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
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