The U.S. Food and Drug Administration (FDA) has approved the first biosimilar product in the U.S.
The drug, dubbed Zarxio (filgrastim-sndz), is biosimilar ("highly similar to an already-approved biological product") to Amgen Inc.'s Neupogen, the FDA reported. Biological products are those derived from living organisms such as yeasts or even humans and animals.
Zarxio is approved for the same applications as Neupogen, which includes prescriptions 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. "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 approval of this new biosimilar drug was based on "structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data." The most common side effects seen with the newly-approved drug include aching in the bones and muscles as well as irritation at the injection site. Serious side effects can occur such as spleen rupture, serious allergic reaction, and acute respiratory distress syndrome.
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act and creates an abbreviated licensure pathway for biological products that can be proven to be biologically similar to those that have already been FDA approved. It allows biosimilar biological product to be licensed based on "less than a full complement of product-specific preclinical and clinical data," the FDA stated.
