FDA Schedules Public Hearing on Insulin Biosimilars

April 9, 2019

The FDA will hold a May 13 public hearing to discuss ways to improve the efficiency of biosimilar insulin development.

Former FDA Commissioner Scott Gottlieb said the transition of insulin from the drug to the biologics pathway “will open up these products to biosimilar competition.” The agency is already seeing “robust activity among sponsors seeking to bring forward biosimilar copies of insulin,” he said.

Participants planning to present at the hearing must register by April 29. Those who wish to merely attend or speak at the event must register by May 9, the agency said.

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