High
cost.
High
value.
UDENYCA® delivers the high-quality treatment and outcomes you expect with Neulasta® (pegfilgrastim), but with significant cost savings for your patients and practice.1,2
Safe,
effective,
affordable
Safe, effective, affordable
Biosimilars are safe, effective, and affordable alternatives to existing brand biologics and meet the same manufacturing and quality standards set by the US Food and Drug Administration (FDA). Biosimilars can help control costs while delivering quality care to patients who need it.3
Coherus BioSciences brings CHOICE WITHOUT COMPROMISE
Coherus BioSciences was established in 2010 with the mission to improve patient access to high-quality biologics for life-altering diseases by leveraging the biosimilar regulatory pathway.
CUTTING-EDGE
ANALYTICS
Quality from the start—from our state-of-the-art laboratory in California, we developed proprietary analytical methods to closely evaluate all aspects of the molecule.
PROCESS &
MANUFACTURING
Quality every step of the way, with a manufacturing process based in the United States that ensures both product purity and reliability.
CLINICAL &
REGULATORY EXPERTISE
With an eye on efficiency, we design and execute studies to align with the latest regulatory guidance to demonstrate biosimilarity.
INTELLECTUAL
PROPERTY
We invest in discovering proprietary technologies to speed development of biosimilars to patients in need.
CUTTING-EDGE
ANALYTICS
Quality from the start—from our state-of-the-art laboratory in California, we developed proprietary analytical methods to closely evaluate all aspects of the molecule.
PROCESS &
MANUFACTURING
Quality every step of the way, with a manufacturing process based in the United States that ensures both product purity and reliability.
CLINICAL &
REGULATORY EXPERTISE
With an eye on efficiency, we design and execute studies to align with the latest regulatory guidance to demonstrate biosimilarity.
INTELLECTUAL
PROPERTY
We invest in discovering proprietary technologies to speed development of biosimilars to patients in need.
The need for UDENYCA®
Lack of
competition
has enabled
cost increases
Lack of competition has enabled cost increases
The cost of Neulasta® has increased by more than 100% since 2006.4
Although Centers for Medicare & Medicaid Services (CMS) and insurers have taken on a greater share of the increasing costs, patients also share in this cost burden through larger co-pay and co-insurance premiums. Increasing cost reduces access for patients who have a lower ability to pay for supportive care.5
Patients and
providers share
the cost burden
Patients and providers share the cost burden
UDENYCA®
offers a choice
UDENYCA® offers a choice
Coherus developed UDENYCA®, a biosimilar product to the reference product Neulasta®. Availability of a biosimilar introduces competition and controls costs while delivering quality supportive care to patients who need it.3
Cost savings
Biosimilars could help save nearly $250 billion in the next 10 years.3
Cost
savings
References: 1. UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019. 2. First Databank, Inc. Pricing Compendia. 3. Biosimilars overview. Biosimilars Forum. Accessed May 19, 2020. http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_overview_032816opt_-_copy_0.pdf 4. US Bureau of Labor Statistics: SHA National Data. MAT. November 2016. 5. Meropol NJ, Schulman KA. Cost of cancer care: issues and implications. J Clin Oncol. 2007;25(2):180-186.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION:
Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.
- 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: Permanently discontinue UDENYCA® in patients with serious allergic reactions.
- Fatal sickle cell crises: Have occurred.
- Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA® if causality is likely.
WARNINGS AND PRECAUTIONS:
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.
INDICATION
UDENYCA® 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.
Limitations of Use
UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
