FDA Approves Fylnetra, a Biosimilar for Neulasta, to Treat Neutropenia in Patients With Cancer

The Food and Drug Administration (FDA) approved Fylnetra (pegfilgrastim-pbbk), a biosimilar to Neulasta, a drug administered after chemotherapy to promote the growth of new and healthy white blood cells to prevent neutropenia, according to Amneal Pharmaceuticals, the company developing the drug.

The biosimilar is indicated for use in patients with non-myeloid malignancies who are receiving myelosuppressive cancer treatment that is associated with an increased risk of febrile neutropenia.

Biosimilars are drugs that are not identical but have a similar treatment effect as the reference product — in this case Neulasta. To become FDA-approved, a biosimilar product must not have any clinically meaningful differences in outcomes compared to the reference product.

Unlike generic drugs, biosimilars are made from living organisms, though both have the potential to bring down the cost of cancer treatments.

READ MORE: The Outlook Is Hopeful That Biosimilars Will Mimic Effectiveness of Original Cancer Drugs for Less Money

Fylnetra is administered via injection once per chemotherapy cycle, though it should not be given between 14 days prior and 24 hours after a patient received cytotoxic chemotherapy. Adults can expect to receive 6 milligrams of the drug, while pediatric dosing for children 45 kilograms (99 pounds) or less is based on weight.

Like other pegfilgrastim-based products, Fylnetra works by binding to neutrophil surface receptors and stimulating proliferation of white blood cells.

The most common side effects, occurring in 5% or more of patients receiving Fylnetra, were bone pain and extremity pain. According to the biosimilar’s prescribing information, patients who have a history of serious allergic reactions to human granulocyte colony-stimulating factors like pegfilgrastim or filgrastim should not receive Fylnetra.

Amneal noted that it plans to launch Fylnetra — along with two other biosimilars, Releuko (filgrastim-ayow), which references Neupogen and Alymsys(bevacizumab-maly), referencing Avastin — in the second half of 2022.

“Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible,” Chirag and Chintu Patel, co-CEOs of Amneal, said in a press release.

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