2026 FDLI Annual Conference

On May 6, Axinn partner Aziz Burgy will speak on the panel “Do You Copy? Biosimilars, Generics, Fast Tracks and Fine Prints” at the 2026 FDLI Annual Conference, taking place May 6-7 in Washington, DC, and virtually.

Panelists will discuss how the FDA is advancing generics and biosimilars by streamlining evidence requirements—including using PK/PD and immunogenicity data—easing interchangeability, speeding approvals, promoting formulation transparency, and addressing skinny labeling and induced infringement. For biosimilars, speakers will cover biosimilar evidentiary standards; for generics, ANDA evidentiary standards and legislative developments, including GDUFA reauthorization.