Source: U.S. Food and Drug Administration
Interchangeable Biosimilars
Jun 6, 2023 · 1m 35s
https://www.youtube.com/watch?v=i0IJg511J5Q
FDA approval of interchangeable biosimilars can increase patient access to critical treatments at potentially lower costs. When a biosimilar is approved as interchangeable, it may be substituted for the reference product at the pharmacy without the intervention of the prescriber, depending on state pharmacy laws. For FDA approval, biological product manufacturers must provide additional data that reflect how the interchangeable biosimilar may be used in the marketplace with patients.
As with generic drugs, patients who receive their medications through their pharmacies may switch between a reference product and an interchangeable biosimilar. To assess the safety of switching, studies may be conducted with patients alternating between the reference product and the proposed interchangeable biosimilar. The results from these studies are compared to results from patients who are being treated just with the reference product. These studies ensure there is
no change in the safety risk or effectiveness when switching between the two products. While this additional information helps to determine the safety of pharmacy-level substitution, it doesnt mean that interchangeable biosimilars are safer or more effective than other biosimilars. FDAs rigorous standards help ensure that all approved interchangeable biosimilars are as safe and effective as their reference products. For more information, explore the FDAs biosimilar resources for health
care professionals at fda.gov/biosimilars.
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