Name: #633: Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonization Efforts
Start: 2026-06-17T13:45:00-0400
End: 2026-06-17T14:45:00-0400

#633: Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonization Efforts

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-672-L04-P; CME 1.00; RN 1.00

EU’s Reflection Paper introduces a tailored clinical approach for biosimilars, driving an optimised and efficient development programme by reducing unnecessary studies, as regulators and industry discuss opportunities for patient access and global harmonization.

Learning Objectives

Describe the scientific basis and regulatory rationale behind the EU’s tailored clinical approach for biosimilar development; Discuss how enhanced analytical similarity assessments can support leaner clinical development programs; Explain circumstances under which comparative clinical efficacy studies may be reduced or waived.

Chair

Peter Richardson

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Speakers

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands

Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
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Credit Type ACPE, CME, RN
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DIA 2026 Global Annual Meeting

Peter Richardson

Steffen Thirstrup

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Success you have shared X tickets.

DIA 2026 Global Annual Meeting

Peter Richardson

Steffen Thirstrup

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