The U.S. Food and Drug Administration (FDA) has approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States.
A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Sandoz, Inc’s filgrastim-sndz is biosimilar to Amgen Inc’s filgrastim (Neupogen), which was originally licensed in 1991. Filgrastim-sndz is approved for the same indications as filgrastim and can be prescribed by a health-care professional for patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy, and patients with severe chronic neutropenia.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, MD. “Patients and the health-care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy, and quality standards.”
The BPCI Act
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act, which President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biologic products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic product, called the “reference product.” This abbreviated licensure pathway permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product and enables a biosimilar biologic product to be licensed based on less than a full complement of product-specific data.
A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s), and strength(s) as the reference product and only for the indication(s) and condition(s) of use that have been approved for the reference product.
The FDA’s approval of filgrastim-sndz is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, and other clinical safety and effectiveness data that demonstrate filgrastim-sndz is biosimilar to filgrastim. Filgrastim-sndz has been approved as biosimilar, not as an interchangeable product. (Under the BPCI Act, a biologic that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health-care provider who prescribed the reference product.) ■