90 FR 156 pgs. 39395-39397 - Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments
Type: NOTICEVolume: 90Number: 156Pages: 39395 - 39397
Pages: 39395, 39396, 39397Docket number: [Docket No. FDA-2025-N-2787]
FR document: [FR Doc. 2025-15572 Filed 8-14-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2787]
Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of public workshop; request for comments.
SUMMARY:
[top] The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Interchangeable Products: Identifying Future Needs." The purpose of the public workshop is to address a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for
DATES:
The hybrid public workshop will be held on September 19, 2025, from 9 a.m. to 1 p.m. Eastern Time, and will take place in person and virtually. Either electronic or written comments on this public workshop must be submitted by October 19, 2025. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ADDRESSES:
The public workshop will be held in person at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room, Silver Spring, MD 20993-0002, and virtually using the Microsoft Teams platform. In-person participants must be REAL ID compliant to access federal facilities. For additional information regarding REAL ID, refer to https://www.dhs.gov/real-id/real-id-faqs. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time on October 19, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
Instructions: All submissions received must include the Docket No. FDA-2025-N-2787 for "Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments." Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Sarah Ikenberry, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm 1128, Silver Spring, MD 20993-0002, 301-796-6893, sarah.ikenberry@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is hosting a hybrid public workshop entitled "Advancing the Development of Interchangeable Products: Identifying Future Needs," in accordance with the commitment in section II.D.3 of the BsUFA III commitment letter. The purpose of the public workshop is to seek stakeholder input on potential areas that need to be addressed to facilitate the development of interchangeable biosimilar products. Input received during the workshop will inform the development of a draft strategy document that outlines specific actions FDA will take to facilitate the development of interchangeable biosimilar products and that FDA will publish, for public input, within 12 months following the workshop.
II. Topics for Discussion at the Public Workshop
[top] FDA and industry stakeholders invited by FDA will provide perspectives on future needs for the development of interchangeable biosimilar products. Additionally, FDA subject matter experts will discuss product quality considerations for biosimilars (including interchangeable biosimilars) and considerations around interchangeability from the perspective of user interface and human factor aspects related to delivery devices as well as other considerations around interchangeability of biological products. Following speaker presentations, presenters will participate in a moderated panel
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the following website: https://www.fda.gov/industry/fda-public-workshop-future-needs-development-interchangeable-products-09192025. Please indicate either in-person or virtual attendance and provide complete contact information for each attendee, including name and email.
Registration is free for both in-person and virtual attendance. In-person attendance is based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by Friday, September 19, 2025, at 9 a.m. Eastern Time for in-person registration. Virtual attendees can register and join at any time through the conclusion of the meeting. Early registration for in-person attendance is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8:30 a.m. We will let registrants know if registration closes before the day of the public workshop.
If you need special accommodations due to a disability, please contact Sarah Ikenberry, 301-796-6893, sarah.ikenberry@fda.hhs.gov no later than September 12, 2025.
Although FDA verified the website addresses in this document, please note that websites are subject to change over time.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: August 12, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15572 Filed 8-14-25; 8:45 am]
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