Amneal Pharmaceuticals and Kashiv Biosciences have received FDA approval for Fylnetra® (pegfilgrastim-pbbk), a biosimilar of Amgen’s Neulasta® (pegfilgrastim).

• Fylnetra is the fifth Neulasta biosimilar approved in the United States. It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients who have nonmyeloid malignancies and are receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Recommended dosing is based on the patient’s weight. Fylnetra is given subcutaneously once per chemotherapy cycle. It should not be given between 14 days before or 24 hours after administration of cytotoxic chemotherapy.
• Launch and pricing information for Fylnetra are not yet available.