Find out what INTERCHANGEABILITY can mean for you.
What makes a biosimilar and an Interchangeable biosimilar different?
To be designated an Interchangeable biosimilar, the FDA requires
ADDITIONAL EVIDENCE.1
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First, an Interchangeable biosimilar must meet the high FDA standards of a biosimilar — ie, proven to be highly similar structurally to its reference product and no clinically meaningful differences in safety, potency, and purity.1
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An Interchangeable designation requires an additional study of multiple substitutions in patients — an Interchangeability study.1* This study shows how patients do when they are switched back and forth from a reference product to the Interchangeable biosimilar.1 The Interchangeability study is designed to give providers confidence that patients can be switched with no increased risk in terms of safety or diminished efficacy, as compared to remaining on the reference product.2
*One or more studies may be required by the FDA to demonstrate Interchangeability.
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According to the FDA, prescribers and patients “can expect that the Interchangeable product will have the same clinical result as the reference product in any given patient.”2
And they “can be confident in the safety and effectiveness of an Interchangeable product, just as they would be for an FDA-approved reference product.”3
Substitution made easier
The high level of proof—an additional Interchangeability study—enables an Interchangeable biosimilar to be auto-substituted for a reference product by a pharmacist.3*
*Regulations vary by state.
Lower healthcare costs and greater access
Like biosimilars, Interchangeable biosimilars can be more cost effective for the healthcare system—and, ultimately, your patients.1
References:
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1. US Food & Drug Administration website. Biosimilar product regulatory review and approval. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf. Accessed November 24, 2020.
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2. US Food & Drug Administration website. Biosimilar and interchangeable products. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed November 24, 2020.
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3. US Food & Drug Administration website. Biological product definitions. https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf. Accessed November 24, 2020.