The FDA approved pegfilgrastim-jmdb (Fulphila) as the first biosimilar to pegfilgrastim (Neulasta), a drug designed to reduce the risk of febrile neutropenia in patients treated with chemotherapy in certain types of cancer, according to a press release issued by the FDA.
The biosimilar is intended to treat patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
The FDA’s approval was based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The agency noted that pegfilgrastim-jmdb has been approved as a biosimilar, not as an interchangeable product, though biosimilars have no clinically meaningful difference in terms of safety, purity, and potency.
"Today's approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the US,” said Rajiv Malik, president of Mylan, the company that developed the drug in partnership with Biocon.
The most common side effects of pegfilgrastim-jmdb include bone pain and pain in extremities. Serious treatment-related side effects were rupture of the spleen, acute respiratory distress syndrome, serious allergic reactions, acute inflammation of the kidney, an abnormally high level of white blood cells, capillary leak syndrome and the potential for tumor growth. The agency added that fatal sickle cell crises have occurred.
“Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access,” said FDA Commissioner Scott Gottlieb, MD. “We’ll continue to prioritize reviews of these products to help ensure that biosimilar medications are brought to the market efficiently and through a process that makes certain that these new medicines meet the FDA’s rigorous standard for approval,” he added.
Gottlieb also noted that the FDA intends to release a comprehensive new plan to advance new policy efforts that promote biosimilar product development.
“We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”
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