US FDA final guidance on interchangeable biosimilars

Ned Sharpless, Acting Commissioner of the US Food and Drug Administration, has issued a statement outlining final guidance aimed at helping bring interchangeable biosimilars to market.

While fully interchangeable biosimilars are  more common in Europe, the regulation around biosimilars in the USA is different. The ‘interchangeable’ designation is legally defined as: “expected to produce the same clinical result as the reference product in any given patient."

In the USA, without being granted this designation, the reference product cannot be swapped for the biosimilar without a doctor’s sanction.