Boosts
absolute
neutrophil
count.
Boosts
absolute
neutrophil
count.*
*While expanding patient access.
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 |
|
|
| *The assays used to assess immunogenicity for UDENYCA® were highly sensitive and demonstrated no treatment-emergent neutralizing antibodies in more than 300 subjects. | ||
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 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.
References: 1. UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019. 2. Data on file. Coherus BioSciences, Inc.; 2020. 3. Neulasta® (pegfilgrastim) package insert. Thousand Oaks, CA: Amgen Inc.; 2020. 4. 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 May 19, 2020. https://www.fda.gov/media/82647/download 5. 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 June 1, 2020. https://www.fda.gov/media/88622/download
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.
