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 …
On April 24, 2024, the FDA issued a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products – Questions and Answers, (the “Revised Draft Guidance”) which replaces the Agency’s initial draft guidance issued in February …
While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. This of course, make sense—after decades of …
Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). As has been explained, the BPCIA provided an abbreviated pathway to market for follow-on biologics—biosimilars and interchangeable biosimilars—and with …
FDA, like much of the rest of the world, has been adjusting to the rapid changes in our world these last few years. For nearly three years following the declaration of the COVID-19 health emergency, there were no in-person meetings held. Then, in early 2023, …
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials AND a critical competency for legal and business professionals in the biopharmaceutical arena AT THE American Conference Institute’s (ACI’s) 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA! Attend ACI’s Hatch-Waxman and BPCIA Proficiency …
On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 1067, the “Ensuring …
