One year after hosting a public workshop (“Advancing the Development of Interchangeable Products: Identifying Future Needs”), and as part of its BSUFA III commitments, FDA, on September 18, 2026, published for comment a strategy document entitled “BsUFA III Future Needs in the Development of Interchangeable …
The American Conference Institute’s (ACI’s) virtual 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 20-29, 2026 (Eastern Standard Time). Led by an experienced faculty, the virtual training series is specifically designed for attorneys, regulatory affairs professionals, …
This is the second in our series analyzing the riders attached to the FY 2026 Labor-HHS Appropriations Bill. This installment examines the drug-related provisions, which cover a wide range of topics from accelerated approval and rare disease therapies to biosimilars and opioid regulation. The Committee’s …
Last week, FDA released its Justification of Estimates for Appropriations Committees for the Agency’s Fiscal Year 2027 (“FY2027”) budget request. Prior budget requests included a separate document titled “FDA Legislative Proposals” (see, e.g., here, here, here, and here; and our prior post here). The FY2027 …
The FDA continues to refine its approach to biosimilar development. On March 9, 2026, the Agency announced the release of the revised draft guidance titled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4).” The guidance updates FDA recommendations for biosimilar …
The American Conference Institute’s (“ACI”) FDA Boot Camp returns March 25-26, 2026, at the New York City Bar, New York, NY. This foundational training brings together life sciences attorneys, in-house counsel, and compliance professionals to dissect FDA law, policy, and enforcement trends. What You’ll Gain: A clear …
On December 3, 2025, the U.S. Food and Drug Administration held its public meeting on the upcoming reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028–2032, known as BsUFA IV. The meeting gave regulators, manufacturers, and other stakeholders an opportunity to outline …
FDA has announced a public meeting and request for comment on proposed recommendations for the next reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032. BsUFA allows FDA to collect user fees to support the review of biosimilar biological products. …
Biosimilars, costing about 50% of their reference products, have generated $56 billion in healthcare savings since 2015, with $20 billion saved in 2024 alone. Compared to the small molecule market though, that’s pocket change. It should come as no surprise therefore that FDA is actively …
The American Conference Institute’s (ACI’s) virtual 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 14-30, 2025 (Eastern Standard Time). The virtual training series is specifically designed for attorneys, regulatory affairs professionals, and industry executives …
“Inter Partes Review” and “Section 101” are not terms you typically run into on this all-things-FDA blog, but we have talked about such patent-related issues before (here and here), and they are important legal (patent) principles, particularly in the context of drug and biological products …
The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024. This virtual three-week program is designed to give new lawyers and executives a solid foundation in the essentials and intricacies of …
There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this …
The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the …
In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable …
