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  4. The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products - 05/13/2019 - 05/13/2019
  1. FDA Meetings, Conferences and Workshops

Public Hearing

Event Title
The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products
May 13, 2019


Date:
May 13, 2019
Time:
09:00 AM - 02:45 PM EDT
Location:
Event Location
Great Room B
Building 31, FDA White Oak campus

10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
United States




Insulin is a life-saving drug that many Americans depend on to treat their diabetes. In recent years, however, increases in the prices of insulin products have raised serious concerns about the ability for many patients to access the insulin needed to survive. The FDA is 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 entrance for public meeting participants (non-FDA employees or contractors) is through Building 1, where routine security check procedures will be performed. For parking, security and other visitor information, please refer to Public Meetings at the FDA White Oak Campus.

Registration

Please use Eventbrite to register for in-person or webcast attendance.

If you need special accommodations due to a disability, please contact Allison Hoffman, Ph.D., at 301-796-9203 or OMPTFeedback@fda.hhs.gov at least 7 days before the public hearing.

Background Information

Meeting Information

Submitting Comments

Regardless of attendance at the public meeting, you can submit electronic or written comments to the public docket by May 27, 2019. Submit electronic comments to Regulations.gov. Submit written comments to the Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

All comments must be identified with the docket number FDA-2019-N-1132. The FDA may post, without change, all comments received to Regulations.gov, including any personal information provided.

Questions

If you have questions about registering for the meeting, contact Allison Hoffman, Ph.D., U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, phone: 301-796-9203, or email: OMPTFeedback@fda.hhs.gov.