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This webinar will use case studies to illustrate how to comply with regulatory requirements and expectations for the analytical and clinical development of biosimilar mAbs.

Starts

June 25, 2014

Ends

June 25, 2014

Join us for a one hour webinar on Analytical & Clinical Development of Biosimilar mAbs: From Vision to Reality.

This webinar will use case-studies to illustrate:

  • Regulatory requirements for physicochemical characterization, including the implications of the revised EMA overarching guidelines and the FDA concept of “fingerprint-like” analysis.
  • Comparability strategies for primary and higher order structure, particularly for antibodies where their size and complexity requires LC/MS/MS.
  • Regulatory expectations for clinical development including
    • Acceptance and use of equivalence/non-inferiority studies
    • Extrapolation of indications
    • Evaluation of immunogenicity
    • Interchangeability
    • Pharmacovigilance

About the Presenters

Dr. Alex Kudrin, Celltrion Inc
Vice-President, Head of Global Development and Vice-Chair of Medical Management Committee
MBBS Hon, MSc, PhD, MD, MBA, MRCP (UK), ECPM

Dr. Fiona M. Greer
Global Director for Biopharma Services Development
SGS Life Science Services