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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Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
US Bill Urges Automatic Insulin Interchangeability
A draft Biosimilar Insulin Access Act, intended to waive US interchangeability requirements for FDA-approved biosimilar insulins, has been introduced by representative Glenn Grothman.
How Might FDA Be Convinced To Change Biosimilar Naming Policy?
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.