FDA Calls For Switching Studies To Support Biosimilar Interchangeability

January 17, 2017 at 8:16 PM
FDA will require switching studies as well as consumer testing to determine interchangeability of a biosimilar, according to a highly anticipated draft guidance released Tuesday (Jan. 17). While one industry expert called the guidance “very conservative” and argued sponsors would incur significant costs complying with certain requirements, the head of a stakeholder group funded in part by industry praised the guidance for its groundbreaking and flexible approach. The agency is also asking stakeholders to weigh in on questions regarding how...


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