Interchangeability of biosimilars in the US

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The US Food and Drug Administration (FDA) has different requirements for biosimilars depending on whether they are defined as ‘biosimilar’ or ‘interchangeable’ [1].

Whitehouse V17D07

FDA issued draft guidance on the interchangeability of biosimilars in January 2017 [2]. In the guidance the agency makes it clear that biosimilars makers will first have to prove that their product is ‘biosimilar’ to the reference biological. Then, in order to claim ‘interchangeability’ for the biosimilar, additional information must be submitted.

Where the product has been approved as a biosimilar (and not interchangeable), the physician must specify the name of the product if they want to prescribe a biosimilar. Whereas when the product has also been approved as interchangeable, substitution of the reference product with the biosimilar may be allowed. This, however, will be subject to state laws, as FDA policy on approval standards does not address biosimilar substitution.

Twenty-five US States and Puerto Rico have passed legislation relating to interchangeable biosimilars.

Most of the state legislation uses compromise automatic substitution language supported by brand-name and biosimilars makers and unveiled by the Generic Pharmaceutical Association (GPhA) in 2014 [3].

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1. Derbyshire M. Interchangeability of biosimilars in the US and around the world. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):97-8. doi:10.5639/gabij.2017.0602.017
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 9]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Compromise reached on US legislation on biosimilars substitution []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 9]. Available from:

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