Session-8a-Streamlining-Biosimilar-Development

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Session 8: Streamlining and Harmonizing Biosimilar Development

Session Chair(s)

Christopher J. Webster, DVM, PHD, MS, MSC

Principal, BioApprovals, United States

Vast experience has been gained in the development of biosimilars over the past decade, which can enable the streamlining of biosimilar developments by allowing specific reductions of regulatory requirements without compromising the quality or safety of the product. Moreover, there is a broad interest of patients that such opportunities are pursued vigorously, as the elimination of unnecessary regulatory requirements contributes to competition within the biosimilars’ market and the eventual affordability of, and access to, biosimilars. This session will examine new proposals for streamlining the development of biosimilars and consider the circumstances under which such new approaches might be introduced and the issues to be confronted in harmonizing these approaches across the world.

Learning Objective : Upon completion of this session, the participant should be able to:
Be aware of potential new directions for the evolution of regulatory requirements for the development of biosimilars and the scientific bases for them
Understand how such new regulatory requirements might be introduced into current development paradigms
Be able to design efficient global development plans for biosimilars taking advantage of new regulatory approaches

Speaker(s)

Christopher J. Webster, DVM, PHD, MS, MSC

Principal, BioApprovals, United States

Efficient Development of Biosimilars: A Rumsfeldian Approach

Martin Schiestl, PHD

Global Head Regulatory Affairs Policy, Sandoz GmbH, Austria

Tailored Clinical Biosimilar Development

Guido Pante, PHD

Technical Officer, World Health Organization , Switzerland

Update on the WHO Pilot Procedure for Prequalification of BTPs: Rituximab and Trastuzumab