Immunogenicity Assessment for the Successful Development of Biosimilars
Conference Recording Apr 15, 2013
About the SpeakerMichael G. TOVEY, Ph.D, is INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, CNRS UMR 8113 at the Ecole Normale Supérieure, Cachan, France. He is the author of more than 200 articles on interferon, cytokines, biotechnology, and immunogenicity. He is a member of numerous scientific boards and is French representative for the ISICR International Council. He is chair of the International Cytokine Standards Committee, a member of the ISICR Meetings Committee, and a member of the European Adjuvant Advisory Committee. He is editor-in-chief of Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations, Associate Editor of the Journal of Interferon and Cytokine Research and a member of the Editorial Board of the Journal of Immunoassay & Immunochemistry and the Scientific World Journal.
Successful development of biosimilars requires the establishment of a validated and standardized assay that allows direct comparisons of the relative potency and immunogenicity of innovator molecules and biosimilars as illustrated by case studies for interferon beta products and TNF-alpha antagonists.