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Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonisation Efforts
Session Chair(s)
Peter Richardson, PHD
Head of Quality, Specialised Scientific Disciplines Department
European Medicines Agency, Netherlands
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 harmonisation.
Learning Objective : 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 programmes; Explain circumstances under which comparative clinical efficacy studies may be reduced or waived.
Speaker(s)
Steffen Thirstrup, MD, PHD
European Medicines Agency, Netherlands
Chief Medical Officer
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