Coherus BioSciences Submits 351(k) Biologics License Application to U.S. Food and Drug Administration for CHS-1701 (Pegfilgra...
August 09 2016 - 1:54PM
Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced submission
of the biologics license application (BLA) for CHS-1701, a
pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under
the 351(k) pathway.
The BLA submission is supported by similarity
data from analytical, pharmacokinetic, pharmacodynamic and
immunogenicity studies comparing CHS-1701 and Neulasta.
“The CHS-1701 BLA submission marks a significant
milestone in our ongoing transition to a commercial company in a
transformational year for Coherus as we continue to focus on
execution of our strategic plan,” said Denny Lanfear, President and
CEO of Coherus BioSciences. “Pegfilgrastim is the largest
selling oncology product in the U.S., and CHS-1701 is the
cornerstone of our oncology franchise. We believe we have a strong,
competitive and order-of-entry position with this product. We
anticipate our oncology portfolio to include an Avastin®
biosimilar, as well as other oncology biosimilar product
candidates.”
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 receive BLA acceptance from the FDA, 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 March
31, 2016, filed with the Securities and Exchange Commission on May
9, 2016 and its future periodic reports to be filed with the
Securities and Exchange Commission.
Neulasta® is a registered trademark of Amgen
Inc. Avastin® is a registered trademark of Genentech.
Contact:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
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