UDENYCA^® provides the established outcomes you expect for your patients

UDENYCA^® was confirmed to be highly similar to Neulasta^® (pegfilgrastim), with no clinically meaningful differences.^1,2

Approval based on extensive data analysis and stringent FDA requirements³

Clinical studies with UDENYCA^® were conducted in healthy subjects, the most sensitive and informative population in which to assess biosimilarity.⁴

A study in healthy subjects is likely to produce less pharmacokinetic/pharmacodynamic (PK/PD) variability compared with a study in patients with potential confounding factors such as underlying and/or concomitant disease and concomitant medications such as myelosuppressive chemotherapy
Healthy subjects are fully immunocompetent and can mount an immune antidrug antibody (ADA) response
Lack of confounding factors in healthy subjects allows for better evaluation of treatment-related adverse events (AEs) that are specific to pegfilgrastim

Clinical studies in cancer patients to confirm biosimilarity of UDENYCA^® to Neulasta^® were not required by the FDA.

Establishing biosimilarity for UDENYCA^®

The FDA recommends a stepwise approach
for biosimilar development^3,4

Reference product
development

Biosimilar development

Reference product
development

The stepwise approach for biosimilars is different from the developmental model used for reference products, in which clinical trial data in the intended patient population provide the basis for approval³

Biosimilar development

In the biosimilar development paradigm, the analytical assessment forms the foundation of the totality of evidence, and the nonclinical data, together with pharmacokinetics/ pharmacodynamics (PK/PD), immunogenicity, and safety data, support the demonstration of biosimilarity³

UDENYCA^® is dosed and administered identically to Neulasta^® PFS.^1,2

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References: 1. UDENYCA^® (pegfilgrastim-cbqv) Prescribing Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023. 2. Neulasta^® (pegfilgrastim) Prescribing Information. Thousand Oaks, CA: Amgen Inc.; 2021. 3. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. Published April 2015. Updated April 24, 2020. Accessed April 27, 2023. https://www.fda.gov/media/82647/download. 4. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. Published December 2016. Accessed April 27, 2023. https://www.fda.gov/media/88622/download.

INDICATION

UDENYCA^® (pegfilgrastim-cbqv) 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: 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.

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 granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. 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.

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.

G-CSF expanded use during COVID-19 pandemic

As a result of the current COVID-19 pandemic, the National Comprehensive Cancer Network^® (NCCN^®) and American Society of Clinical Oncology (ASCO^®) have offered short-term recommendations specific to issues with COVID-19 (SARS-CoV-2) for hematopoietic growth factors, as related to the on-label use of our product. The recommendations include the expanded prophylactic use of granulocyte colony-stimulating factor (G-CSF), such as pegfilgrastim, to reduce the potential number and length of hospitalizations for cancer patients undergoing various chemotherapy treatments. Please see important limitations to these recommendations outlined below.

UPDATED RECOMMENDATIONS

The short-term recommendations include a lowered threshold for the use of myeloid growth factors from those chemotherapy regimens that have a 20% or higher risk of febrile neutropenia to now include those regimens with a 10%-20% risk of febrile neutropenia, which includes all of the intermediate risk chemotherapy regimens.^1,2

CAUTION: Physicians may wish to avoid use of or discontinue G-CSF in cases of respiratory infection, respiratory symptoms, or confirmed or suspected COVID-19 to avoid increase in pulmonary inflammation or hypothetical risk of increasing inflammatory cytokines associated with adverse outcome.

For further information from each organization:

NCCN is providing resources from the leading cancer centers that comprise the nonprofit alliance and sharing them all online at NCCN.org/covid-19. The site will be updated as new resources become available. For information specifically on changes to the myeloid growth factors guidelines, please see NCCN.org/covid-19/pdf/HGF_COVID-19.pdf.

ASCO has provided guidance on how to care for patients experiencing potential neutropenic fever and neutropenia who are affected by the ongoing COVID-19 pandemic. This guidance can be found online at ASCO.org.

If you have any questions on these guidelines, please call our Medical Affairs team at 1-800-483-3692.

References: 1. Referenced with permission from the National Comprehensive Cancer Network, Inc. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed April 9, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. COVID‑19 patient care information. American Society of Clinical Oncology (ASCO). Updated April 23, 2020. Accessed May 1, 2020. https://www.asco.org/asco-coronavirus-information/care-individuals-cancer-during-covid-19

UDENYCA® provides the established outcomes you expect for your patients

UDENYCA® was confirmed to be highly similar to Neulasta® (pegfilgrastim), with no clinically meaningful differences.1,2

Establishing biosimilarity for UDENYCA®

The FDA recommends a stepwise approach for biosimilar development3,4

Reference product development

Biosimilar development

Reference product development

Biosimilar development

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

G-CSF expanded use during COVID-19 pandemic

UPDATED RECOMMENDATIONS

For further information from each organization:

UDENYCA^® provides the established outcomes you expect for your patients

UDENYCA^® was confirmed to be highly similar to Neulasta^® (pegfilgrastim), with no clinically meaningful differences.^1,2

Establishing biosimilarity for UDENYCA^®

The FDA recommends a stepwise approach
for biosimilar development^3,4

Reference product
development

Reference product
development