First Biosimilar Product Approved by the FDA
A biosimilar product is a biological agent that is approved based on a demonstration that is highly similar to an already approved biological agent, called the reference product. It can only be approved 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) that has been approved for the reference product.
Zarxio is biosimilar to Neupogen (filgrastim; Amgen) and is indicated 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.
The approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data that showed Zarxio is biosimilar to Neupogen. Zarxio is not interchangeable with Neupogen.
For more information visit FDA.gov.