Fylnetra FDA Approval History
Last updated by Judith Stewart, BPharm on May 31, 2022.
FDA Approved: Yes (First approved May 26, 2022)
Brand name: Fylnetra
Generic name: pegfilgrastim-pbbk
Dosage form: Injection
Company: Amneal Pharmaceuticals LLC
Treatment for: Neutropenia Associated with Chemotherapy
Fylnetra (pegfilgrastim-pbbk) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of neutropenia in patients undergoing chemotherapy.
- Fylnetra is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
- Fylnetra was approved as a biosimilar based on data demonstrating that it is highly similar to the FDA-approved biological reference product containing pegfilgrastim, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
- Fylnetra is administered subcutaneously via a single-dose prefilled syringe.
- Patients should be made aware of the following risks associated with the use of Fylnetra: splenic rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell crises, and glomerulonephritis.
- Common adverse reactions include bone pain and pain in extremities.
- Fylnetra is the fifth FDA-approved pegfilgrastim biosimilar, after the approvals of Nyvepria (pegfilgrastim-apgf), Ziextenzo (pegfilgrastim-bmez ), Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb).
Development timeline for Fylnetra
| Date | Article |
|---|---|
| May 27, 2022 | Approval FDA Approves Fylnetra (pegfilgrastim-pbbk), a Biosimilar to Neulasta |
Further information
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