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# FDA Schedules Insulin Biosimilar Public Hearing
- URL: https://www.fdaweb.com/fda-schedules-insulin-biosimilar-public-hearing/
- Published: 2019-04-02T12:00:00.000Z
- Updated: 2026-09-15T01:17:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143754

FDA will hold a 5/13 public hearing to discuss access to affordable insulin products and issues related to development and approval of biosimilars and interchangeable insulin products. A *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-06438.pdf?ref=fdaweb.com) says the agency wants to hear input from patients, families, healthcare providers, and other stakeholders who live with diabetes or care for someone with diabetes about the challenges and opportunities it should consider in preparing for submission and review of applications for biosimilar and interchangeable insulin products. “We also want to hear from manufacturers and other stakeholders about the development process for biosimilar and interchangeable insulin products,” the notice says.

Issues FDA would like participants to discuss are: 

- scientific standards for evaluating the biosimilarity and interchangeability of an insulin product;
- other regulatory considerations;
- patient experience; and
- information resources for patients, clinicians, pharmacists, and other stakeholders.

In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634999.htm?ref=fdaweb.com) announcing the hearing, FDA commissioner **Scott Gottlieb** reviews the “serious concerns” about price increases in insulin and the difficulties in developing and approving generic products to increase competition. He says that at the hearing, FDA wants to “hear from stakeholders about what factors the agency should consider when evaluating data and other information submitted by an applicant, including from analytical and clinical studies, to determine whether an insulin product is biosimilar or interchangeable to a reference product. We also want stakeholder feedback on whether certain insulin products, for example those that use insulin pumps for continuous subcutaneous infusion among the approved uses or those approved with over-the-counter marketing status, raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products, and this input will inform FDA’s approach to implementing the regulatory pathway for biosimilar and interchangeable insulin products.”