Fylnetra, a Biosimilar to Neulasta, Gets FDA Approval

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.

Fylnetra is the fifth pegfilgrastim biosimilar approved by the FDA. Other approved biosimilars include Fulphila (Mylan), Nyvepria (Pfizer), Udenyca (Coherus Biosciences), and Ziextenzo (Sandoz).

References

1. 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
2. Fylnetra. Package insert. Amneal; 2022. Accessed May 27, 2022. https://amneal.com/wp-content/uploads/2022/05/FYLNETRA-PI.pdf