Learning Tracks

Practices Related to Q1/Q2 Similarity Requirements

Monday, October 2, 2023

1:30 p.m. - 3:00 p.m.

In this session, industry representatives will explore Q1/Q2 assessments in the product development phase of ANDAs and how some brand companies attempt to block access to affordable generics. Pending the outcome of potential legislation that may address the concerns of Q1/Q2 assessments, this session also may explore this legislative update as well.


Cindy Chang, J.D., M.S.
Counsel, IP and Litigation, Hikma Pharmaceuticals USA Inc.

Ryan Daniel, J.D.
Vice President, Associate General Counsel, Corporate and Business Transactions, Biopharmaceuticals, Fresenius Kabi, LLC

Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs, Apotex Corp.

Harshil Parikh, M.S.
Principal Product Development Scientist, Formulations, Teva Pharmaceuticals