FDA Approves First Biosimilar to Reduce Risk of Infection During Cancer Treatment

The Food and Drug Administration (FDA) approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to reduce the risk for febrile neutropenia in patients treated with chemotherapy in certain types of cancer, according to a press release issued by the FDA.

"I couldn't be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the U.S., as it represents an important milestone for patients and further demonstrates Mylan's continued fight to expand access to medicine,” Heather Bresch, CEO of Mylan — the biosimilar’s co-manufactuer – said in a statement. “(The) FDA's approval of this product, as well as the agency's continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients.”

Febrile neutropenia is defined as fever or other signs of infection with a low count of neutrophils — a type of infection-fighting white blood cell.

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.

A biosimilar, which is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA, has no clinically meaningful difference in terms of safety, purity and potency.

In this instance, 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 Fulphila has been approved as a biosimilar, not as an interchangeable product.

The most common side effects of Fulphila 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.

FDA Commissioner Scott Gottlieb, M.D., highlighted the agency’s desire to bring new biosimilars to patients to help “promote competition that can reduce drug costs and promote access.”

“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.

“Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health,” he said. “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.”