Coherus’ Marketing Authorization Application to European Medicines Agency for CHS-1701 (Pegfilgrastim Biosimilar Candidate)...
November 29 2016 - 9:00AM
Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced acceptance
of a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) for CHS-1701, a pegfilgrastim (Neulasta®)
biosimilar candidate. This represents the first EMA
submission and acceptance for Coherus BioSciences.
The CHS-1701 MAA is supported by biosimilarity
data from analytical, pharmacokinetic, pharmacodynamic and
immunogenicity studies comparing CHS-1701 and Neulasta.
“The CHS-1701 MAA submission marks our first to
the EMA and follows our CHS-1701 filing with the FDA. We believe
this filing provides the basis for good partnering opportunities
for CHS-1701 in the European markets in the first half of 2017,”
said Denny Lanfear, President and CEO of Coherus BioSciences.
“We will continue to focus on strong execution across all
aspects of the business plan and look forward carrying this
momentum into next year.”
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
in Europe and the U.S. and to partner 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 September 30, 2016, filed
with the Securities and Exchange Commission on November 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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