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Are US Interchangeability Studies Worth It?

Biosimilar Switching Studies May Not Be Worth The Effort, Sponsors Say

Executive Summary

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.

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