Boosts
absolute
neutrophil
count.

Boosts
absolute
neutrophil
count.*
*While expanding patient access.

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UDENYCA® was confirmed to be highly similar to Neulasta® (pegfilgrastim), with no clinically meaningful differences.1-3

  Neulasta® UDENYCA®
  Highly similar or bioequivalent
Molecular structure
 
Biological function
 
Absolute neutrophil count (ANC) pharmacodynamics
 
Drug pharmacokinetics
 
Safety profile
 
Immunogenicity profile*
 
Drug stability
 
Drug purity
 

Approval based
on extensive
data analysis and
stringent FDA
requirements4

Approval based on extensive data analysis and stringent FDA requirements4

Clinical studies with UDENYCA® were conducted in healthy subjects, the most sensitive and informative population in which to assess biosimilarity.5

  • 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 anti-drug 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.

References: 1. UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019. 2. Data on file. Coherus BioSciences, Inc.; 2018. 3. Neulasta® (pegfilgrastim) package insert. Thousand Oaks, CA: Amgen Inc.; 2018. 4. US Department of Health and Human Services, Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Published April 2015. Accessed November 7, 2018. 5. US Department of Health and Human Services, Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product: guidance for industry. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm397017.pdf. Published December 2016. Accessed November 7, 2018.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION:

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

    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: 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.

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.

Please see Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION:

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

    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: 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.

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.

Please see Full Prescribing Information.