What makes a biosimilar and an Interchangeable biosimilar different?

A biosimilar is a biological medicine proven to work in the same way as an approved reference biologic, with no clinically meaningful differences in terms of safety, potency and purity.¹

Interchangeability is a distinct FDA designation. To attain it, a biosimilar must undergo an additional study*, called an Interchangeability Study, which shows how patients do when they are switched back and forth from the reference product to the Interchangeable candidate.¹

Only when a biosimilar gains Interchangeable status from the FDA can it be called an Interchangeable biosimilar. It can then be automatically substituted at the pharmacy, depending on state laws.²

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

_{*One or more studies may be required by the FDA to demonstrate Interchangeability.}

_{References: 1. US Food & Drug Administration website. Biosimilar Product Regulatory Review and Approval. Accessed September 10, 2021. https://www.fda.gov/files/drugs/published/Biosimilar-Product- Regulatory-Review-and-Approval.pdf 2. US Food & Drug Administration website. Prescribing biosimilar and interchangeable products. Accessed September 9, 2021. https://www.fda.gov/drugs/biosimilars/prescribing-biosimilar-andinterchangeable-products}