Are US Interchangeability Studies Worth It?
Biosimilar Switching Studies May Not Be Worth The Effort, 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.
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A draft Biosimilar Insulin Access Act, intended to waive US interchangeability requirements for FDA-approved biosimilar insulins, has been introduced by representative Glenn Grothman.
Following FDA/FTC workshop, several stakeholders urge FDA to do away with suffixes for biosimilar names while others seek reconsideration of switching studies for interchangeability.