Legal and Policy

Legal and Policy Issues Currently Facing the Industry
Be a part of the discussions on pressing challenges facing the industry. We will explore the future landscape of patent issues affecting generics and biosimilars and review what the recent drug pricing changes in the Inflation Reduction Act mean for future generic and biosimilar competition. We will discuss what the user fee legislation and its proposed policy riders mean for FDA review of generic and biosimilar applications. Finally, we will assess the current state and future challenges for biosimilar competition.

Who should attend:

Possible job titles include:
Regulatory Affairs, Medical Affairs, Business Development, Program Management, Policy, Commercial Development, Scientific Affairs, Research Analyst

About GRx+Biosims 2022

GRx+Biosims 2022 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory and policy professionals. Top officials and subject-matter experts share their knowledge and best practices to enhance attendees’ understanding of how to succeed in generic and biosimilar development; the regulatory process and approvals; and the evolving policy landscape.