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Virtual

Oct 05, 2021 10:00 AM - Oct 06, 2021 5:00 PM

(US Eastern Standard Time)

Biosimilars Conference

This event is now offered in a new entirely virtual format.

Session 3: How Different Is Too Different? Differentiation Opportunities and Challenges for Biosimilars

Session Chair(s)

Leah  Christl, PhD

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)

Eva  Temkin, JD

US and EU Framework and Differentiation Opportunities

Eva Temkin, JD

King & Spalding LLP, United States

Partner, FDA and Life Sciences

Irene Z. Chan, PharmD

Speaker

Irene Z. Chan, PharmD

FDA, United States

Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,

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