Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS),
a commercial-stage biopharmaceutical company focused on the
research, development and commercialization of innovative
immunotherapies to treat cancer, today announced that the U.S. Food
and Drug Administration (FDA) approved UDENYCA ONBODY™, the
company's on-body injector (OBI) presentation of UDENYCA®
(pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the
day after chemotherapy to decrease the incidence of infection as
manifested by febrile neutropenia.
“The on-body injector for UDENYCA is the result of
years of significant investment in research and development to
bring forward a novel and proprietary device that provides patients
with an automatic delivery option for their medication,” said Denny
Lanfear, CEO of Coherus. “Cancer patients and their physicians will
now be able to choose the UDENYCA administration presentation that
best fits their individual needs: a prefilled syringe, our
autoinjector, or this on-body injector.”
“Our market studies showed a significant demand for
a novel on-body pegfilgrastim delivery device tailored to specific
patient needs. We expect that UDENYCA ONBODY’s five-minute
injection time and innovative retractable needle mechanism will be
well received by cancer patients, their caregivers, and doctors,”
said Paul Reider, Coherus’ Chief Commercial Officer.
“Our state-of-the-art UDENYCA ONBODY device is
unlike other approaches in that it is not adapted or repurposed
from other medical uses,” said Rich Hameister, Coherus’ Chief
Technical Officer. “This is a clean sheet, grounds-up, de novo
approach designed for pegfilgrastim administration that applies
proprietary technology and user insights to produce a reliable and
highly intuitive patient experience.”
UDENYCA ONBODY was designed with patients in mind;
key features include an indicator and status light and auditive
signal that help patients confirm the dose has been administered
and a strong and well-tolerated adhesive. After the dose is
administered, the needle automatically retracts, which reduces the
risk of needlestick injury.
The approval of UDENYCA ONBODY was supported by a
comprehensive analytical and clinical data package, including
pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence data
as well as adhesive performance and tolerability data.
Commercial availability of UDENYCA ONBODY is
planned for the first quarter of 2024.
About UDENYCA
UDENYCA® is the only pegfilgrastim brand
approved in the United States available in three administration
options—prefilled syringe (PFS), autoinjector (AI) and
OBI—providing patients and healthcare providers with choice,
control, and convenience. Since its launch in 2019, over 300,000
patients have been treated with UDENYCA.
INDICATIONUDENYCA® is a
leukocyte growth factor indicated to:
- Decrease the incidence of infection, as manifested by febrile
neutropenia, in patients with non-myeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with a clinically
significant incidence of febrile neutropenia.
- Increase survival in patients acutely exposed to
myelosuppressive doses of radiation (Hematopoietic Subsyndrome of
Acute Radiation Syndrome).
Limitations of Use: UDENYCA® is not indicated
for the mobilization of peripheral blood progenitor cells for
hematopoietic stem cell transplantation.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Patients with a history of
serious allergic reactions to pegfilgrastim products or filgrastim
products. Reactions have included anaphylaxis.
WARNINGS AND PRECAUTIONS:
- Fatal splenic rupture: Evaluate patients who report left upper
abdominal or shoulder pain for an enlarged spleen or splenic
rupture.
- Acute respiratory distress syndrome (ARDS): Evaluate patients
who develop fever, lung infiltrates, or respiratory distress.
Discontinue UDENYCA® in patients with ARDS.
- Serious allergic reactions, including anaphylaxis: The majority
of reported events occurred upon initial exposure. Allergic
reactions, including anaphylaxis, can recur within days after the
discontinuation of initial anti-allergic treatment. Permanently
discontinue UDENYCA® in patients with serious allergic
reactions.
- Allergies to Acrylics: The on-body injector (OBI) for UDENYCA
uses acrylic adhesive. For patients who have reactions to acrylic
adhesives, use of this product may result in a significant
reaction.
- Sickle cell crises: Severe and sometimes fatal crises have
occurred. Discontinue UDENYCA® if sickle cell crisis
occurs.
- Glomerulonephritis: The diagnoses were based upon azotemia,
hematuria (microscopic and macroscopic), proteinuria, and renal
biopsy. Generally, events resolved after dose reduction or
discontinuation. Evaluate and consider dose-reduction or
interruption of UDENYCA® if causality is likely.
- Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or
greater have been observed in patients receiving pegfilgrastim
products. Monitoring of complete blood count (CBC) during
UDENYCA® therapy is recommended.
- Thrombocytopenia: Thrombocytopenia has been reported in
patients receiving pegfilgrastim. Monitor platelet counts.
- Capillary Leak Syndrome: Has been reported after G-CSF
administration, including pegfilgrastim products, and is
characterized by hypotension, hypoalbuminemia, edema, and
hemoconcentration. Episodes vary in frequency, severity and may be
life-threatening if treatment is delayed. If symptoms develop,
closely monitor and give standard symptomatic treatment, which may
include a need for intensive care.
- Potential for Tumor Growth Stimulatory Effects on Malignant
Cells: The possibility that pegfilgrastim products act as a growth
factor for any tumor type, including myeloid malignancies and
myelodysplasia, diseases for which pegfilgrastim products are not
approved, cannot be excluded.
- Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
in Patients with Breast and Lung Cancer: MDS and AML have been
associated with the use of pegfilgrastim in conjunction with
chemotherapy and/or radiotherapy in patients with breast and lung
cancer. Monitor patients for sign and symptoms of MDS/AML in these
settings.
- Potential Device failures: Missed or partial doses have been
reported for products administered via on-body injectors due to the
device not performing as intended. In the event of a missed or
partial dose, patients may be at increased risk of events such as
neutropenia, febrile neutropenia and/or infection than if the dose
had been correctly delivered. Instruct patients using the OBI to
notify their healthcare professional immediately to determine the
need for a replacement dose of UDENYCA if they suspect that the
device may not have performed as intended.
- Aortitis: Has been reported in patients receiving pegfilgrastim
products, occurring as early as the first week after start of
therapy. Manifestations may include generalized signs and symptoms
such as fever, abdominal pain, malaise, back pain, and increased
inflammatory markers (e.g., c-reactive protein and white blood cell
count). Consider aortitis when signs and symptoms develop without
known etiology. Discontinue UDENYCA® if aortitis is
suspected.
- Nuclear Imaging: Increased hematopoietic activity of the bone
marrow in response to growth factor therapy has been associated
with transient positive bone imaging changes. Consider when
interpreting bone imaging results.
ADVERSE REACTIONS: Most common adverse reactions (≥
5% difference in incidence compared to placebo) are bone pain and
pain in extremity.
To report SUSPECTED ADVERSE REACTIONS,
contact Coherus BioSciences at 1-800-4-UDENYCA
(1-800-483-3692) or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Full Prescribing Information available
at www.UDENYCA.com
- Neulasta prescribing information
- UDENYCA prescribing information
About Coherus
BioSciencesCoherus 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.
Coherus’ immuno-oncology pipeline 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 is a novel anti-IL-27 antibody currently being
evaluated in two on-going clinical studies: a Phase 1/2 study in
advanced solid tumors and a Phase 2 study in hepatocellular
carcinoma. CHS-114 is a highly selective, competitively positioned,
ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as
a monotherapy in patients with advanced solid tumors.
Coherus’ earlier-stage immuno-oncology pipeline
targets immune-suppressive mechanisms, including CHS-006, a
TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical
trial in combination with LOQTORZI 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®, YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®
and plans to launch LOQTORZI™ (toripalimab-tpzi), a novel next
generation PD-1 inhibitor, in the U.S. in January 2024.
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 Coherus’
ability to launch UDENYCA® ONBODY, maintain Coherus’
commercial capabilities and identify synergies between its
commercial capabilities and its immuno-oncology pipeline; Coherus’
expectations that its immuno-oncology product candidates will
enhance patient outcomes; Coherus’ projections about the demand for
UDENYCA® ONBODY and its reception after it is launched.
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 September 30, 2023, filed with the Securities and
Exchange Commission on November 6, 2023, including the
section therein captioned “Risk Factors” and in other documents
that Coherus files with the Securities and Exchange
Commission.
UDENYCA®, CIMERLI®, YUSIMRY™, LOQTORZI™ and UDENYCA
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.
Contact Information:For Investors
& Media:Jami Taylor, Head of Investor RelationsCoherus
BioSciencesIR@coherus.com
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