Interchangeable Biosimilar Designations Shouldn't Be Forever, Innovators Say

US FDA may need to withdraw previous interchangeability determination due to new indications or manufacturing changes, reference product companies say; generic firms say prior interchangeability designation should apply to new indications absent significant scientific questions.

The US FDA should establish a formal, transparent mechanism for withdrawing an interchangeability determination if a biosimilar no longer meets the standard, some innovator companies believe.

In comments on FDA’s draft interchangeability guidance, the Biotechnology Innovation Organization (BIO) and Amgen Inc. urge FDA to delineate...

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