戻る Agenda
Session 3: How Different Is Too Different? Differentiation Opportunities and Challenges for Biosimilars
Session Chair(s)
Leah Christl, PhD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States
Biosimilars are required to be similar to their reference product, but what does that truly mean? When competing for market share, it may be helpful to stand out from the crowd. But what is a helpful differentiation and when is different too different? Global regulatory frameworks for biosimilars vary in their prescriptive nature, leaving the door open for potential regulatory flexibility. This session will explore the opportunities for biosimilar manufacturers to differentiate their biosimilar while still meeting the regulatory requirements for biosimilarity.
Learning Objective : At the conclusion of this session, participants should be able to:
- Distinguish biosimilar product differentiation opportunities within the global regulatory framework
- Evaluate development complexities and challenges when considering biosimilar differentiation
Speaker(s)
US and EU Framework and Differentiation Opportunities
Eva Temkin, JD
King & Spalding LLP, United States
Partner, FDA and Life Sciences
Speaker
Irene Z. Chan, PharmD
FDA, United States
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,