FDA’s Greatest Biosimilar Impact May Be Interchangeability Policy, Sandoz Says

As the agency and stakeholders gear up for public hearing, Sandoz argues that since Europe has not addressed interchangeability, FDA could step to the forefront by focusing on it as part of implementing the U.S. biosimilar pathway.

Interchangeability may be where FDA can leave its regulatory mark in the biosimilar arena because European rules have not yet addressed it.

FDA’s three biosimilar guidances were largely silent on interchangeability and the agency has asked for additional comments on this and...

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