FDA Approves Fylnetra, Fifth Biosimilar of Neulasta, for Febrile Neutropenia
Key Insights
The FDA has approved Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Neulasta, developed by Amneal Pharmaceuticals and Kashiv Biosciences (search).
Fylnetra is indicated to treat or prevent febrile neutropenia (search) in cancer patients undergoing chemotherapy, addressing a critical need in supportive cancer care.
This approval marks the fifth pegfilgrastim biosimilar in the US, the third biosimilar approval for Amneal, and the second drug approval for Kashiv Biosciences (search).
The U.S. Food and Drug Administration (FDA) has granted approval to Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Neulasta (pegfilgrastim), for reducing the incidence of febrile neutropenia (search) in patients undergoing chemotherapy. Developed by Amneal Pharmaceuticals and Kashiv Biosciences (search), Fylnetra represents the fifth pegfilgrastim biosimilar to receive FDA approval, offering a potentially more affordable alternative to the reference product.
Addressing Febrile Neutropenia in Cancer Patients
Pegfilgrastim products are crucial in managing the side effects of chemotherapy, particularly febrile neutropenia (search), a condition characterized by fever and a dangerously low count of neutrophils, a type of white blood cell essential for fighting infection. Chemotherapy often suppresses the production of neutrophils, leaving patients vulnerable to severe infections. Fylnetra, like other pegfilgrastim products, stimulates the production of neutrophils, thereby reducing the risk of infection and allowing patients to continue their cancer treatment on schedule.
Expanding Biosimilar Availability
Fylnetra's approval follows that of other pegfilgrastim biosimilars, including Nyvepria (pegfilgrastim-apgf), Ziextenzo (pegfilgrastim-bmez), Udenyca (pegfilgrastim-cbqv), and Fulphila (pegfilgrastim-jmdb). This increasing availability of biosimilars is expected to drive down the cost of these essential medications, improving access for patients who need them most. For Amneal Pharmaceuticals, Fylnetra marks their third biosimilar approval in the U.S., following Releuko (filgrastim-ayow (search)) and Alymsys (bevacizumab-maly (search)), which reference Neupogen and Avastin, respectively. Kashiv Biosciences (search) celebrates its second drug approval with Fylnetra, building on their successful partnership with Amneal.
Launch Plans and Future Prospects
Amneal Pharmaceuticals has announced plans to launch Fylnetra, along with Releuko and Alymsys, during the second half of 2022. This launch will further expand the availability of biosimilar options for cancer patients, potentially leading to significant cost savings for both patients and healthcare systems. Chandramauli Rawal, MBBS, chief operating officer for Kashiv Biosciences (search), expressed enthusiasm for the approval, stating, "Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years."