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.