Defined
Approach.

Confirmed
Biosimilarity.

Next

Analytical,
nonclinical,
and clinical
studies

Analytical, nonclinical, and clinical studies

Biosimilarity is demonstrated based on the totality of the evidence showing that a proposed biosimilar product is highly similar to the reference product and that there are no clinically meaningful differences between the biosimilar and the reference product. Biosimilar development programs are designed in accordance with US Food and Drug Administration (FDA) guidance and with the agency’s advice and feedback.1

Biosimilarity is demonstrated through analytical, nonclinical, and clinical studies1

  • FDA reviews the totality of data beginning with a foundation of detailed analytical characterization
  • Comparative clinical studies are needed
    only if required by the FDA
  • FDA reviews the totality of data beginning with a foundation of detailed analytical characterization
  • Comparative clinical studies are needed only if required by the FDA

Clinical Studies

Comparative

Clinical Studies

PK/PD, safety, and
immunogenicity

Animal Studies

including toxicity assessment

Analytical Studies

of structure and function

FDA recommends a stepwise approach for biosimilar development

— If required by the FDA

— If required
by the FDA

Establishing
biosimilarity for
UDENYCA

The stepwise approach for biosimilars is different from the development model used for reference products, in which clinical trial data in the intended patient population provide the basis for approval. 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 biosimilarity.1

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

References: 1. 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. 2. UDENYCA (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 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 or hematopoietic stem cell transplantation.

Please see Full Prescribing Information, Patient Information, and Instructions for Use.

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 UDENYC 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 or hematopoietic stem cell transplantation.

Please see Full Prescribing Information, Patient Information, and Instructions for Use.