First Biosimilar to Pegfilgrastim Approved by FDA

The FDA has approved pegfilgrastim-jmdb (Fulphila, Mylan GmbH) as the first biosimilar to pegfilgrastim (Neulasta). The drug is used to decrease the chance of infection, with fever, associated with an abnormally low number of infection-fighting white blood cells in patients with nonbone marrow cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

“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, in a press release. “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."

The FDA’s approval of pegfilgrastim-jmdb is 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 that demonstrates that pegfilgrastim-jmdb is biosimilar to pegfilgrastim. Pegfilgrastim-jmdb has been approved as a biosimilar, not as an interchangeable product.

The most common adverse effects of pegfilgrastim-jmdb are bone pain, and pain in extremities. Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim products, are advised not to take pegfilgrastim-jmdb. Serious adverse effects from treatment with pegfilgrastim-jmdb include rupture of the spleen, acute respiratory distress syndrome, serious allergic reactions (including anaphylaxis), acute inflammation of the kidney, an abnormally high level of white blood cells, capillary leak syndrome, and the potential for tumor growth. Fatal sickle cell crises also have occurred.

According to Gottlieb, the FDA is planning to release a comprehensive new plan this summer to advance new policy efforts that promote biosimilar product development. "Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. 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,” said Gottlieb, in a statement.

Reference

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment [news release]. Silver Spring, MD: June 4, 2018; FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm. Accessed June 4, 2018.