FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections
September 25 2023 - 8:30AM
Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), a
commercial-stage biopharmaceutical company focused on the research,
development, and commercialization of innovative immunotherapies to
treat cancer, announced today that the U.S. Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL)
regarding the Biologics License Application (BLA) supplement for
UDENYCA® ONBODY™, the company's on-body injector (OBI) presentation
of UDENYCA® (pegfilgrastim-cbqv), solely due to an ongoing review
of inspection findings at a third-party filler. The CRL did not
identify any issues with the UDENYCA® ONBODY™ clinical efficacy or
safety, trial design, labeling, drug substance manufacturing, or
device design or manufacturing, and no additional data or trials
have been requested. Coherus is committed to working closely with
the FDA and the third-party filler to bring UDENYCA® ONBODY™ to
cancer patients requiring pegfilgrastim treatment as quickly as
possible.
Coherus also announced completion of FDA’s toripalimab
inspectionsCoherus also announced today that the FDA has
completed the clinical study site inspections of three clinical
sites in China that enrolled subjects in the two pivotal clinical
trials supporting the toripalimab BLA for the treatment of
metastatic or recurrent nasopharyngeal carcinoma (NPC) as
first-line treatment or as second or greater line treatment. Only
one site received an FDA Form 483, with one observation noted.
Coherus believes the observation is readily addressable. Coherus
continues to anticipate potential approval for toripalimab by year
end 2023.
“We are pleased the FDA has completed the review elements for
the OBI and toripalimab applications,” said Dr. Theresa LaVallee,
Coherus Chief Development Officer. “We will work with the
third-party filler to address the issues and resubmit the UDENYCA®
ONBODY™ application as quickly as possible. Having completed
all the required review elements of the toripalimab BLA, we will
continue to work collaboratively with the FDA to bring toripalimab,
with its substantial improvement in survival compared to
chemotherapy, to NPC patients. NPC is a rare cancer with high
unmet medical need that has no drugs approved for treatment of this
disease in the U.S.”
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused
on the research, development and commercialization of innovative
immunotherapies to treat cancer. Coherus is developing an
innovative immuno-oncology pipeline that will be synergistic with
its proven commercial capabilities in oncology.
Through an in-licensing agreement with Shanghai Junshi
Biosciences Ltd., Coherus is developing toripalimab, an anti-PD-1
antibody, in the United States and Canada. A BLA for toripalimab
for the treatment of nasopharyngeal carcinoma is under review by
the FDA. Toripalimab is approved in China for the treatment of
melanoma, urothelial cancer, esophageal squamous cell carcinoma,
nasopharyngeal carcinoma and non-small cell lung cancer.
Through its acquisition of Surface Oncology, Coherus’
immuno-oncology pipeline now includes multiple antibody
immunotherapy candidates focused on enhancing the innate and
adaptive immune responses to enable a robust immunologic response
and enhance outcomes for patients with cancer. Casdozokitug
(SRF388) is a novel anti-IL-27 antibody currently being evaluated
in Phase 1/2 clinical trials in lung and liver cancer. CHS-114
(SRF114) is a highly selective, competitively positioned anti-CCR8
antibody currently in a Phase 1/2 study as a monotherapy in
patients with advanced solid tumors. There are also two
out-licensed partnership programs to advance its next-generation
cancer therapies.
Coherus’ earlier-stage immuno-oncology pipeline targets
immune-suppressive mechanisms in the tumor microenvironment,
including CHS-006, a TIGIT-targeted antibody, being evaluated in a
Phase 1/2 clinical trial in combination with toripalimab in
patients with advanced solid tumors, and CHS-1000, a preclinical
program targeting the novel pathway ILT4.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of
Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®,
and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®.
Forward-Looking Statements
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, statements regarding whether Coherus’
innovative immuno-oncology pipeline will be synergistic with its
proven commercial capabilities in oncology and whether the FDA’s
Form-483 observations will be readily addressable and have no
impact on approval timing .
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, risks related to our existing and potential
collaboration partners, the risks and uncertainties inherent in the
clinical drug development process; risks relating to competition;
risks of the drug development position of Coherus’ competitors; the
risks and uncertainties of the regulatory approval process,
including the speed of regulatory review, international aspects of
Coherus’ business, and the timing of Coherus’ regulatory filings;
the risk of FDA review issues; and the risks and uncertainties of
possible litigation. All forward-looking statements contained in
this press release speak only as of the date of this press release.
Coherus undertakes no obligation to update or revise any
forward-looking statements. For a further description of the
significant 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 fiscal quarter
ended June 30, 2023, filed with the Securities and
Exchange Commission on August 2, 2023, including the
section therein captioned “Risk Factors” and in other documents
that Coherus files with the Securities and Exchange
Commission.
UDENYCA®, CIMERLI®, YUSIMRY™ and ONBODY™, whether or not
appearing in large print or with the trademark symbol, are
trademarks of Coherus, its affiliates, related companies or its
licensors or joint venture partners unless otherwise noted.
Trademarks and trade names of other companies appearing in this
press release are, to the knowledge of Coherus, the property of
their respective owners.
Coherus Contact Information:For Investors:Marek
Ciszewski, J.D., SVP Investor RelationsIR@coherus.com
For Media:Jodi Sievers, VP Corporate
Communicationsmedia@coherus.com
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