The U.S. Food and Drug Administration has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia, in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
FDA’s Commissioner Scott Gottlieb said that bringing new biosimilars to patients is a top priority for the FDA, and a key part of its efforts to help promote competition that can reduce drug costs and promote access. He said that the FDA will continue to prioritize reviews of such 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 standard for approval. “This summer, we’ll 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. 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,” Gottlieb said.
Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar 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 (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA’s approval of Fulphila 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 Fulphila is biosimilar to Neulasta. Fulphila has been approved as a biosimilar, not as an interchangeable product.
Mylan CEO Heather Bresch said: “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. As a leading supplier of cancer medicines in the U.S, Mylan is committed to offering affordable and accessible solutions for patients with cancer at every step of their journey. Enhancing access to treatment has always been our top priority and what we’ll continue to deliver to the healthcare system in the U.S. and beyond.”
Mylan president Rajiv Malik said that the approval of Fulphila, the first biosimilar to Neulasta, joins other recent examples such as the approval of Ogivri, the first biosimilar to Herceptin, in the growing portfolio of complex medicines that Mylan is making available for patients who need them.