FDA Holding Hearing on Biosimilar Insulin

On Monday, May 13, the U.S. Food and Drug Administration (FDA) will be holding a public hearing on biosimilar insulin.

A biosimilar[1] is a biological product that is very similar to a reference product, and considered to have no differences that would change what would be expected from the reference product. The FDA is[2] “holding this public hearing to receive input from stakeholders as the Agency prepares for the submission and review of applications for biosimilar and interchangeable insulin products. FDA anticipates that these products, once they are approved, will bring new competition to the insulin market and help provide affordable treatment options to patients with diabetes.”

The hearing will be taking place at 10903 New Hampshire Avenue, Silver Spring, Maryland. To register to attend, either in-person or online, visit this Eventbrite webpage[3], and to watch the webcast, visit the FDA website[4].


Want to learn more about biosimilar insulin? Read “When Will There Be Generic Insulin?”[5]

  1. biosimilar: https://www.diabetesselfmanagement.com/managing-diabetes/treatment-approaches/when-will-there-be-generic-insulin/
  2. The FDA is: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/future-insulin-biosimilars-increasing-access-and-facilitating-efficient-development-biosimilar-and
  3. visit this Eventbrite webpage: https://www.eventbrite.com/e/the-future-of-insulin-biosimilars-a-public-hearing-tickets-56571622245
  4. visit the FDA website: https://collaboration.fda.gov/insulin051319
  5. “When Will There Be Generic Insulin?”: https://www.diabetesselfmanagement.com/managing-diabetes/treatment-approaches/when-will-there-be-generic-insulin/

Source URL: https://www.diabetesselfmanagement.com/blog/fda-holding-hearing-on-biosimilar-insulin/

Diane Fennell: Diane Fennell has been an editor at Diabetes Self-Management magazine since 2003. She is currently the Editorial Director. (Diane Fennell is not a medical professional.)

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