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Hilton Arlington Towers

Sep 20, 2022 7:00 AM - Sep 21, 2022 3:00 PM

950 N Stafford St., Arlington, VA 22203-1813, USA

Biosimilars Conference

Convening Professionals in Biosimilar Development to Discuss the Challenges of Today and the Possibilities of Tomorrow

Session 2b: Product Development Considerations: Regulatory

Session Chair(s)

Rachel  Turow, JD, MPH

Rachel Turow, JD, MPH

Managing Counsel, FDA Regulatory

Walmart, Inc., United States

Eva  Temkin, JD

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)

Amanda  Major

Panelist

Amanda Major

Coherus, United States

Director, Government Affairs and Policy

Deborah  Williams, MS

Panelist

Deborah Williams, MS

Health Policy Insights, LLC, United States

Founder

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