Pegfilgrastim Biosimilar for Treatment of Neutropenia Launches

Amneal Pharmaceuticals, Inc announced the commercial launch of its latest biosimilar, pegfilgrastim-pbbk (Fylnetra), which references Neulasta. The FDA approved the biologics license application for pegfilgrastim-pbbk for the treatment of neutropenia in June 2022.

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“Fylnetra marks our third US biosimilar launch since late last year. 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 payers,” said Harsher Singh, SVP of Amneal Biosciences division, in a press release. “Although it’s only the early innings for the growing biosimilars market, we are focused on becoming a key player over the long-term.”

Pegfilgrastim-pbbk is indicated in a pre-filled single-dose syringe to treat neutropenia, which is a common condition that affects patients undergoing chemotherapy. The drug is a leukocyte growth factor developed to reduce the onset of infection in patients with non-myeloid malignancies administered myelosuppressive anticancer medications associated with a clinically significant rate of febrile neutropenia. Pegfilgrastim-pbbk is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation, according to Amneal.

Pegfilgrastim-pbbk is contraindicated in patients with a history of severe allergic reactions to human granulocyte colony-stimulating factors (G-CSF), including filgrastim or pegfilgrastim products. The most frequently observed adverse effects associated with pegfilgrastim-pbbk with at least a 5% difference in incidence compared with placebo were bone pain and pain in the extremity, according to Amneal.

Further, Amneal listed several warnings and precautions with the use of pegfilgrastim-pbbk, including fatal splenic rupture, acute respiratory distress syndrome, fatal sickle cell crises, severe allergic reactions, including anaphylaxis, kidney injury, decreased platelet count, and increased white blood cell count. Capillary leak syndrome, myelodysplastic syndrome and acute myeloid leukemia, aortitis, and elevated hematopoietic activity of the bone marrow in response to growth factor therapy associated with temporary positive bone imaging changes were also reported following G-CSF administration.

Amneal noted that physicians should be aware of the potential for pegfilgrastim products to act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia. Pegfilgrastim products are not approved for these diseases.

Reference

Amneal Launches Third Biosimilar with FYLNETRA™ (pegfilgrastim-pbbk) in the United States. Amneal Pharmaceuticals. News release. May 16, 2023. https://investors.amneal.com/news/press-releases/press-release-details/2023/Amneal-Launches-Third-Biosimilar-with-FYLNETRA-pegfilgrastim-pbbk-in-the-United-States/default.aspx