Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced
the Company has resubmitted the Biologics License Application (BLA)
Supplement for UDENYCA® ONBODY™, the company's on-body injector
presentation of UDENYCA® (pegfilgrastim-cbqv), to the U.S. Food and
Drug Administration (FDA) for review.
The resubmission of the UDENYCA® ONBODY™ BLA Supplement follows
the completion and satisfactory resolution of the FDA’s review of
inspection findings at a third-party filler, which was the only
issue identified in the Complete Response Letter (CRL) the FDA
issued on September 21, 2023. 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 to bring
UDENYCA® ONBODY™ to cancer patients requiring pegfilgrastim
treatment as quickly as possible.
“We are pleased that resolution of the FDA’s inspection findings
has enabled our rapid resubmission of the UDENYCA® ONBODY™ BLA
supplement. As the CRL identified no other issues with the BLA
supplement, we look forward to working closely with the agency to
complete the review of the UDENYCA® ONBODY™ application in a timely
manner and anticipate potential approval later this year,” said
Theresa LaVallee, Chief Development Officer of Coherus.
“Coherus appreciates the great collaboration with our
third-party manufacturer and the swift and comprehensive actions
taken to address the inspectional issues raised by the agency. We
are all focused on bringing this excellent product to patients as
quickly as possible,” said Rich Hameister, Chief Technical Officer
at Coherus.
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 recent acquisition of Surface Oncology, Inc.,
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
(formerly SRF388) is a novel anti-IL-27 antibody currently being
evaluated in Phase 1/2 clinical trials in lung and liver cancer.
CHS-114 (formerly 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’
immuno-oncology pipeline will have synergies with its commercial
capabilities in oncology; expectations about competitive
positioning of Coherus’ product candidates; and expectations about
the timing or ability for Coherus to achieve approval for any of
its product candidates.
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
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:Jodi
Sievers, VP, Corporate Communicationsir@coherus.com
For Media: Judy Stecker – Hill & Knowlton Senior Vice
President, U.S. Healthcare Media and Public Affairs
Leadjudy.stecker@hkstrategies.com +1 202-355-3493
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