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Session 2b: Product Development Considerations: Regulatory
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
Eva Temkin, JD
Partner, FDA and Life Sciences
King & Spalding LLP, United States
This session will explore the regulatory considerations that go into deciding whether or not to develop a biosimilar. These include the types of studies that will be necessary to support licensure, the potential for interchangeability designation, the regulatory exclusivity environment, and new regulatory considerations related to the Inflation Reduction Act. These myriad factors can alter the business case for development to be positive or negative.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the regulatory factors that go into determining a pathway to biosimilar development
- Explain the FDA regulatory environment for biosimilar and interchangeable development and licensure
- Grasp the significance of multiple forces – regulatory, political, and commercial - that are affecting the viability of the biosimilars market in the US
Speaker(s)
Panelist
Amanda Major
Coherus, United States
Director, Government Affairs and Policy
Panelist
Deborah Williams, MS
Health Policy Insights, LLC, United States
Founder
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