Regulatory agency officials from around the world will be joined by industry representatives to discuss scientific and regulatory issues for biosimilars, including specific requirements for approval of biosimilars, interchangeability and implications for substitution. Discussion of approval requirements will address, among other topics, clinical trials, extrapolation of data and immunogenicity. Naming and pharmacovigilance and the impact of government tendering for biosimilars will also be addressed. How are global health authorities approaching these issues and what are the main challenges and concerns?

Moderator: Thomas Schreitmueller, Head Regulatory Policy Biologics 

Speakers:

Dirceu Barbano, Director Chairman ANVISA;
Peter Richardson, Head of Biologicals, EMA
Claudia Vaca Gonzales, Asesor Despacho Ministro, Ministrof Health and Social Protection, Colombia
David Dorsey, Senior Director, Americas Head, Janssen Research and Development
Agnes Klein, Director, Health Canada
Ricardo H. Cavazos, Chief Economist and Director Gerneral for International Affairs, COFEPRIS
Mikel Arriola Penalosa, Federal Commissioner, COFEPRIS

Session ID: 2094