Workshop 1 : Biosimilar monoclonal antibodies

Sunday 13th of April 2014
09:00-12:30
W1, 3.5 hours

Chair: Anita O’Connor (USA)


 

Meeting room 207

 

 

In June 2013, the European Medicines AMA’s Committee for Medicinal Products for Human Use (CHMP) recommended two infliximab containing monoclonal antibody biosimilar preparations. These positive recommendations included extrapolation to indications for which clinical studies have not yet been conducted with the biosimilar product but rather based on the indications approved for the reference monoclonal antibody. Patent expirations for a number of other high market monoclonal antibody therapeutics are also imminent. This workshop will examine the emerging regulatory framework around this important class of biosimilars and examine clinical, analytical and market frameworks for their introduction.