FDA Workshop Explores Needs for Faster Interchangeable Biosimilars Development
Published Date: 8/15/2025
Notice
Summary
The FDA is hosting a public workshop to explore how to make interchangeable biosimilar products better and easier to develop. This affects drug makers and patients who want more affordable medicine options. The workshop is part of a plan running through 2027 and aims to gather ideas on future research and guidance, potentially speeding up access and saving money.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Workshop on Interchangeable Biosimilars
The FDA is holding a public workshop titled "Advancing the Development of Interchangeable Products: Identifying Future Needs" as part of its Biosimilar User Fee Act (BsUFA) III commitments for fiscal years 2023 through 2027. The workshop will gather ideas on guidance and research that the FDA says may help make interchangeable biosimilar drugs easier to develop, which could speed patient access and help lower costs for people seeking more affordable medicines.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20503, Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
The FDA fixed a previous announcement about Oxandrin tablets (2.5 mg and 10 mg) being pulled from the market due to safety or effectiveness concerns. This update confirms that not only the original drug but also several generic versions were withdrawn and removed from the official drug list. Patients, doctors, and drug makers should note these changes, which affect availability and prescribing options immediately.
Previous / Next Documents
Previous: 2025-15571, Biosimilar User Fee Act III Regulatory Science Program Interim Public Meeting; Public Meeting; Interim Report; Availability; Request for Comments
The FDA is hosting a public meeting to share progress on their Biosimilar User Fee Act III program, which helps speed up the development of biosimilar medicines. This program supports companies making affordable alternatives to brand-name biologic drugs, aiming to make these medicines easier and faster to bring to patients between 2023 and 2027. They’re also asking for ideas on what research to focus on next to keep improving the process.
Next: 2025-15573, Final Environmental Impact Statement for Real Property Master Plan Implementation at Military Ocean Terminal Sunny Point, North Carolina (ID# EISX-007-21-001-1751989587)
The Army is making important upgrades at Military Ocean Terminal Sunny Point in North Carolina to keep the base safe, secure, and ready for its mission. These changes include fixing and improving buildings, waterfront areas, and security features, some of which will happen in flood-prone or wetland areas. The work will follow all safety rules and is planned to happen soon, ensuring the base stays top-notch without costing extra surprises.