Interchangeable Biosimilars: FDA Clarifies US Reference Not Mandatory For Studies
Draft guidance strongly recommends against it, but US FDA's Leah Christl says agency is willing to talk about using foreign-licensed comparators.
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Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.
Industry calls for more education amid concerns that brand sales reps are encouraging providers to use only interchangeable products because they are better than biosimilars.
Boehringer Ingelheim announcement is first public disclosure of interchangeability trial since US FDA draft guidance was released.