The U.S. Food and Drug Administration has approved Zarxio (filgrastim-sndz), becoming the first biosimilar product approved in the United States.
Zarxio is biosimilar to Neupogen (filgrastim) and is approved for the same indications. Zarxio is indicated for patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia (AML) receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection therapy, and patients with severe chronic neutropenia.
A biosimilar product must have the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product and can only be approved by the FDA for the indication(s) and condition(s) of use that that have been approved for the reference product.
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“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “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 most common adverse events associated with treatment with Zarxio are muscle and bone aches and redness and itching or swelling at the injection site.
Serious adverse events include spleen rupture, serious allergic reactions, tachycardia, dyspnea, and tachypnea.