Fylnetra™ (pegfilgrastim-pbbk), a biosimilar to Neulasta® (pegfilgrastim), has been made available by Amneal.
The Food and Drug Administration (FDA) approved Fylnetra, a leukocyte growth factor, based on data demonstrating a high degree of similarity to the reference product, with no clinically meaningful differences. The biosimilar product is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
“Fylnetra marks our third US biosimilar launch since late last year,” said Harsher Singh, SVP of Amneal Biosciences division. “We are excited to be contributing to this next wave of affordable medicines, and we are well positioned to drive access across patients, providers, and payors.
Fylnetra is supplied as a 6mg/0.6mL preservative-free solution in single-dose prefilled syringes for subcutaneous injection.
- Amneal launches third biosimilar with Fylnetra™ (pegfilgrastim-pbbk) in the United States. News release. Amneal. Accessed May 16, 2023. https://www.businesswire.com/news/home/20230516005033/en/Amneal-Launches-Third-Biosimilar-with-FYLNETRA%E2%84%A2-pegfilgrastim-pbbk-in-the-United-States.