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Molly Burich Discusses the FDA's Interchangeability Guidance Update


Molly Burich, MS, head of public policy at Boehringer Ingelheim (BI), discusses how the FDA's new guidance on interchangeability designation will improve confidence and acceptance for biosimilars during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Molly Burich, MS, is the head of public policy at Boehringer Ingelheim.


What are your thoughts on the FDA's updated guidance on interchangeability?

I think the FDA has long been a proponent of not just the biosimilar pathway, but obviously getting interchangeables approved as well. From a guidance perspective, [Boehinger Ingelheim] has felt strongly that the FDA has gotten the guidance right, both in proposed and final form. We believe there does need to be an appropriately high bar, but at the same time, some product-by-product flexibility. We want to make sure that the interchangeability designation is in fact meaningful; that it’s generating a complement of data around patient switching that will help drive physician confidence and patient acceptance as well.

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