Coherus BioSciences Receives Complete Response Letter from FDA for its Biologics License Application for CHS-1701 (Pegfilgras...
June 12 2017 - 6:38AM
Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced that the
U.S. Food and Drug Administration (“FDA”) has issued a complete
response letter (“CRL”) for its biologics license application
(“BLA”) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar
candidate, under the 351(k) pathway.
The CRL primarily focused on the FDA request for
a reanalysis of a subset of subject samples with a revised
immunogenicity assay, and requests for certain additional
manufacturing related process information. The FDA did not
request a clinical study to be performed in oncology
patients. Additionally, the CRL does not indicate additional
process qualification lots would be required or raise concerns over
the GMP status of CHS-1701 bulk manufacturing and fill-finish
vendors.
Coherus will work with the FDA to address the
information requests.
“While we are disappointed in the delay that
this additional request has caused, we remain confident in our
ability to address the FDA’s requests for the purpose of obtaining
approval for CHS-1701,” said Denny Lanfear, President and CEO of
Coherus BioSciences. “We are encouraged that a patient study
has not been requested and we expect that we will be able to
respond to the FDA and meet with them to define a path forward in
the coming months. Neulasta is the largest selling oncology
biologic in the U.S., and we anticipate CHS-1701’s approval will
generate significant U.S. healthcare savings while increasing
patient access.”
Coherus’ management team will host a conference
call on Monday, June 12 at 8:00 a.m. EDT.
Conference Call InformationDial-in: (844)
452-6826 (domestic) or (765) 507-2587
(international) Conference ID: 35568643Please join the
conference call at least 10 minutes early to register.A replay of
this conference call will be posted to the company’s website
http://investors.coherus.com and will be available until July 12,
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 Statements
Except 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, 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 resubmit its BLA with or without
additional studies, and obtain marketing approval for 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, 2017, filed
with the Securities and Exchange Commission on May 8, 2017 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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