ACI Virtual Proficiency Series: Hatch-Waxman and BPCIA

In-Depth Drill-Down on Bioequivalence, “Same Active Ingredient,” and Interchangeability

October 19, 2021


Robins Kaplan LLP is pleased to participate in the ACI Virtual Proficiency Series on Hatch-Waxman and BPCIA taking place October 5-21, 2021. This three-week program on IP basics and regulatory fundamentals relative to small molecules and biologics for brand names, generics, and biopharma, is designed to provide new lawyers and executives for the life sciences industry with a solid foundation for understanding the essentials as well as the intricacies of Hatch-Waxman and BPCIA litigation and regulation.

On Tuesday, October 19, 2021, Jeffrey Alan Hovden spoke in the session titled “In-Depth Drill-Down on Bioequivalence, ‘Same Active Ingredient,’ and Interchangeability.” In this session, presenters discussed 1) defining bioequivalence in drugs and biologics, 2) what an ANDA-filer must demonstrate for bioequivalence, and 3) how bioequivalence relates to patents.