The Food and Drug Administration (FDA) has approved Fylnetra™ (pegfilgrastim-pbbk), a biosimilar to Neulasta® (pegfilgrastim).
Fylnetra, a leukocyte growth factor, 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.
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
The product will be supplied as 6mg/0.6mL preservative-free solution in single-dose prefilled syringes for subcutaneous injection. Amneal Pharmaceuticals expects to launch Fylnetra sometime during the second half of 2022.
- Amneal achieves third U.S. biosimilar approval with Fylnetra™ (pegfilgrastim-pbbk). News release. May 27, 2022. https://www.businesswire.com/news/home/20220527005044/en/Amneal-Achieves-Third-U.S.-Biosimilar-Approval-with-FYLNETRA%E2%84%A2-pegfilgrastim-pbbk
- Fylnetra. Package insert. Amneal; 2022. Accessed May 27, 2022. https://amneal.com/wp-content/uploads/2022/05/FYLNETRA-PI.pdf