FULPHILA (pegfilgrastim-jmdb) · Viatris
Fulphila is a leukocyte growth factor indicated to reduce the risk of infection in patients with non-myeloid malignancies. It is specifically used to decrease the incidence of febrile neutropenia in individuals undergoing myelosuppressive chemotherapy associated with a significant risk of this condition. The drug is not intended for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
How FULPHILA Works
Fulphila belongs to a class of drugs known as colony-stimulating factors that target hematopoietic cells. The medication functions by binding to specific receptors located on the surface of these cells. This binding action stimulates the proliferation, differentiation, commitment, and functional activation of the cells to support the immune system.
Details
- Status
- Prescription
- First Approved
- 2018-06-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FULPHILA Approval History
What FULPHILA Treats
2 indicationsFULPHILA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Non-Myeloid Malignancies
FULPHILA is a lower-cost alternative to Neulasta with no clinically meaningful differences. Requires prescriber approval to substitute.
FULPHILA 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.
What's emerging in FULPHILA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FULPHILA treats. First-in-class if their pivotal trials read out positive.
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Viatris'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.
FULPHILA FDA Label Details
Indications & Usage
FDA Label (PDF)Fulphila 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 Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropeni...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.