Untitled Document
Expert Review on Biosimilars in Oncology and Hematology
Expert review with Matti Aapro, MD, Håkan Mellstedt, MD, PhD, Jos Kosterink, PharmD, PhD, and Luciano Wannesson, MD, focusing on biosimilars in oncology and hematology.
Moderator
Matti Aapro, MD
Clinique de Genolier
Genolier, Switzerland
Discussants
Jos Kosterink, PharmD, PhD
University Medical Center Groningen
Groningen, the Netherlands
Håkan Mellstedt, MD, PhD
Karolinska Institute
Stockholm, Sweden
Luciano Wannesson, MD
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland

Discussion Topics

  • Introduction to biosimilars
  • The biosimilars regulatory approval process
  • Biosimilar monoclonal antibodies
  • Major concerns regarding biosimilar use, including extrapolation, immunogenicity, and traceability
  • Economics of biosimilars

Learning Objectives

  • Compare the safety and efficacy of biosimilar drugs to their originator
  • Analyze major issues of contention regarding biosimilar use, including extrapolation, traceability, and automatic substitution, and propose solutions to address these issues
  • Discuss the positive and negative aspects of biosimilar monoclonal antibody development and use
  • Explain the regulatory approval process for biosimilars with a focus on how this differs from the process for other biologic products














Activity Date

This interview is available from 9 May 2011 to 9 May 2012.

Audience

This educational activity is specifically designed for physicians and other healthcare professionals involved and/or interested in the use of biologic and biosimilar medicines.

Support

This educational activity is supported by Amgen Europe, GmbH and F. Hoffmann-La Roche Ltd.