Amneal Pharmaceuticals, Inc. has announced the commercial launch of its newest biosimilar, pegfilgrastim-pbbk (Fylnetra), referring to Neulasta. The FDA approved a biologics license application for pegfilgrastim-pbbk for the treatment of neutropenia in June 2022.
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“Filnetra will be our third biosimilar launch in the U.S. since late last year. We are well positioned to facilitate access across payers,” said Hersher Singh, Senior Vice President, Amnir Biosciences Division, in a press release. “Although we are still in the early stages of the growing biosimilar market, we are focused on becoming a significant player in the long term.”
Pegfilgrastim-pbbk is indicated in a prefilled single-dose syringe for the treatment of neutropenia, a common condition affecting patients undergoing chemotherapy. This drug was developed to reduce the incidence of infections in patients with non-myelogenous malignancies who are receiving myelosuppressive anticancer drugs with a clinically significant proportion of febrile neutropenia. It is a leukocyte growth factor. According to Amneal, pegfilgrastim-pbbk has not been indicated for the mobilization of peripheral blood progenitor cells in hematopoietic stem cell transplantation.
Pegfilgrastim-pbbk is contraindicated in patients with a history of severe allergic reactions to filgrastim or human granulocyte colony-stimulating factor (G-CSF) containing pegfilgrastim products. According to Amneal, the most frequently observed side effects associated with pegfilgrastim-pbbk, with an incidence difference of at least 5% compared to placebo, were bone pain and extremity pain.
Amnir further lists several warnings and precautions for the use of pegfilgrastim-pbbk, including fatal splenic rupture, acute respiratory distress syndrome, fatal sickle cell disease, Includes severe allergic reactions, including anaphylaxis, kidney damage, low platelet count, and high white blood cell count. count. Increased bone marrow hematopoietic activity in response to growth factor therapy associated with capillary leak syndrome, myelodysplastic syndrome, acute myeloid leukemia, aortitis, and transient positive changes in bone imaging was also reported after G-CSF administration. it was done.
Dr. Amneal noted that physicians need to be aware that pegfilgrastim products can act as growth factors for all types of tumors, including myeloid malignancies and myelodysplasia. Pegfilgrastim products are not approved for these conditions.
reference
Amneal Launches Third Biosimilar with FYLNETRA™ (pegfilgrastim-pbbk) in the US. Anneal 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
