Medications are substances used to treat medical conditions. Traditional medications such as antibiotics and blood pressure medications are called small-molecule agents.
Biologic medications are complex products that are derived from biologic sources (human, animal, microorganisms, or yeast). Biologics include viruses, genes, blood and body tissues, antibodies, toxins or antitoxins, vaccines, and related products used for treating disease. It is not possible to develop chemically identical versions of biologics, but it is possible to develop biologics that have the same safety and efficacy and the same strength dosing as the original biologic, which are typically referred to as biosimilars.
In the United States the U.S. Food & Drug Administration (FDA) requires manufacturers to submit a proposed product for approval as a biosimilar medication or an interchangeable medication, rather than as a generic equivalent. Biosimilar medications are very similar to the original brand-name biologic medication to which they are compared. Only minor differences in clinically inactive components are allowable in biosimilar products. Biosimilar medications are not considered generic because they have large, complex structures and are made from living cells instead of chemicals. Interchangeable medications, additionally, are expected to provide the same benefits and risks as the original brand-name biologic. Zarxio is a biosimilar medication to filgrastim (a medication used in people with cancer to help maintain their white blood cell counts). It was the first medication approved by the FDA as a biosimilar, not as an interchangeable, product. This means that Zarxio may be prescribed by a doctor, but it cannot be substituted (interchanged) for filgrastim by a pharmacist without the approval of the prescribing doctor.In the United States the U.S. Food & Drug Administration (FDA) requires manufacturers to submit a proposed product for approval as a biosimilar medication or an interchangeable medication, rather than as a generic equivalent. Biosimilar medications are very similar to the original brand-name biologic medication to which they are compared. Only minor differences in clinically inactive components are allowable in biosimilar products. Biosimilar medications are not considered generic because they have large, complex structures and are made from living cells instead of chemicals. Interchangeable medications, additionally, are expected to provide the same benefits and risks as the original brand-name biologic. Zarxio is a biosimilar medication to filgrastim (a medication used in people with cancer to help maintain their white blood cell counts). It was the first medication approved by the FDA as a biosimilar, not as an interchangeable, product. This means that Zarxio may be prescribed by a doctor, but it cannot be substituted (interchanged) for filgrastim by a pharmacist without the approval of the prescribing doctor.
Drugs Mentioned In This Article
