UDENYCA (pegfilgrastim-cbqv) · COHERUS BIOSCIENCES INC
UDENYCA (pegfilgrastim-cbqv) is a leukocyte growth factor used to reduce the risk of infection in patients with non-myeloid cancers undergoing myelosuppressive chemotherapy. It is specifically indicated to decrease the incidence of febrile neutropenia associated with these anti-cancer treatments. Additionally, the drug is approved to improve survival rates in individuals who have experienced acute exposure to myelosuppressive doses of radiation. It is not intended for use in the mobilization of peripheral blood progenitor cells for stem cell transplantation.
How UDENYCA Works
UDENYCA functions as a colony-stimulating factor that targets hematopoietic cells within the body. The drug works by binding to specific receptors located on the surface of these cells. This binding process triggers the proliferation, differentiation, and commitment of the cells, leading to their functional activation. By stimulating these biological processes, the medication supports the development and activity of essential white blood cells.
Details
- Status
- Prescription
- First Approved
- 2018-11-02
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
UDENYCA Approval History
What UDENYCA Treats
2 indicationsUDENYCA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Radiation Syndrome
UDENYCA is a lower-cost alternative to Neulasta with no clinically meaningful differences. Requires prescriber approval to substitute.
UDENYCA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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COHERUS BIOSCIENCES INC's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
UDENYCA FDA Label Details
Indications & Usage
FDA Label (PDF)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. Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.