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Are US Interchangeability Studies Worth It?

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

 
• By Sue Sutter

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.

conference
Biosimilars Review & Report's Stan Mehr, Samsung Bioepis' Sang-Jin Pak, Sandoz's Carol Lynch and Mylan's Chrys Kokino talk interchangeability at the AAM meeting. • Source: Sue Sutter

Investing time and resources in a switching study to support an interchangeability designation may not be worthwhile for biosimilar sponsors given the commercial dynamics of the US market, industry representatives said at the Association for Accessible Medicines' recent generics and biosimilars conference.

Representatives from Sandoz Inc., Mylan NV, and Samsung Bioepis Co. Ltd. said the concept of interchangeability, which...

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