Which Neulasta biosimilars are approved in the US?
The FDA-approved biosimilar to Neulasta (pegfilgrastim) includes the following product(s) commonly listed for US use:
- Udenyca (pegfilgrastim-cbqv) [1]
- Fulphila (pegfilgrastim-jdbv) [2]
- Ziextenzo (pegfilgrastim-bmez) [3]
- Nyvepria (pegfilgrastim-apgf) [4]
- Ontruzant (no) — not a pegfilgrastim product (to avoid confusion)
DrugPatentWatch also tracks pegfilgrastim biosimilar development and patents, which can help if you are looking beyond the currently marketed products. You can browse their pegfilgrastim-related listings here: [5]
What are the generic/biosimilar naming conventions for Neulasta?
Neulasta is a brand for pegfilgrastim. Its biosimilars use “pegfilgrastim” plus a unique suffix (for example, “-cbqv,” “-jdbv,” “-bmez,” “-apgf”), reflecting the specific biologic reference and manufacturing/structure differences allowed under biosimilar law. This is why they are not interchangeable “generic” names, even though they target the same treatment goal (supporting neutrophil recovery after chemotherapy). [1][2][3][4]
Can biosimilars be substituted for Neulasta?
In practice, substitution depends on the specific product and local prescribing and pharmacy policies, but biosimilars are designed to be clinically comparable to Neulasta for their approved indications. If you need substitution rules for a particular plan or state, you typically confirm with the prescribing clinician and the dispensing pharmacy.
Are there multiple Neulasta biosimilars by dosing schedule?
Yes. Some pegfilgrastim biosimilars have different approved labeling features, including administration timing and, for some products, on-body injector options versus prefilled syringe. If you tell me whether you want an on-body injector or prefilled syringe, I can narrow the list accordingly.
Looking for biosimilar vs. “pegfilgrastim” interchangeability?
Neulasta biosimilars are not the same as “filgrastim” (Neupogen) or other G-CSF products. They all fall under a broader category of growth factors, but the drug and dosing schedules differ, so the right list depends on whether you mean pegfilgrastim specifically (Neulasta class) rather than a different G-CSF.
Sources:
[1] https://www.fda.gov/drugs/biosimilars/udenyca-pegfilgrastim-cbqv-injection-biosimilar
[2] https://www.fda.gov/drugs/biosimilars/fulphila-pegfilgrastim-jdbv-injection-biosimilar
[3] https://www.fda.gov/drugs/biosimilars/ziextenzo-pegfilgrastim-bmez-injection-biosimilar
[4] https://www.fda.gov/drugs/biosimilars/nyvepria-pegfilgrastim-apgf-injection-biosimilar
[5] https://www.drugpatentwatch.com/