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Interchangeability Won’t Solve US Biosimilar Market’s Woes, FDA’s Gottlieb Says

Executive Summary

FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.

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Are US Interchangeability Studies Worth It?

Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.

Biosimilar Switching Studies May Not Be Worth Effort For US Interchangeability, Sponsors Say

Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.

Biosimilar Sponsors Say Pharmacokinetic Bridging Studies Should Be The Exception, Not The Norm

US FDA guidance runs risk of creating de facto requirement for bridging studies when a biosimilar applicant seeks to use comparative data involving a foreign reference product, Novartis says; IGBA, AAM urge agency adopt a ‘global comparator’ approach that would eliminate the need for clinical bridging studies between US and foreign reference biologics.

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