Insulin Co-op Urges FDA to Abolish Phase 3 Trials for Insulin Biosimilars 

June 7, 2019

The FDA should abandon requirements for Phase 3 clinical trials for insulin biosimilars, an emerging patient co-operative says.

The Insulin Club, a Texas-based co-op of doctors and diabetics says that Phase 3 trials are too expensive and time-consuming. Instead, “a robust chemistry, manufacturing and controls package,” combined with Phase I trial data, ought to be enough to establish a follow-on insulin product.

Insulin is “a small, well understood protein that has been studied for nearly 100 years,” the Club said in a written comment to the FDA.

Contract research organization IQVIA also focused on Phase 3 trials in a comment to the agency. IQVIA didn’t go as far as the Insulin Club but it suggested that the FDA make use of real-world data to speed up Phase 3 trials. Specifically, real-world data can be used to create “an external comparator”—a group of patients who closely match the trial population. The external comparator “would provide multiple benefits to patients and sponsors and, at the same time, would generate a level of evidence of efficacy and safety that has been accepted by the FDA in oncology and rare disease indications,” IQVIA said.

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