'Major Divergences' Spoil WHO's Draft Biosimilar MAb Guidance, Say Generics Firms
This article was originally published in SRA
Executive Summary
The European generic industry body, Medicines for Europe, has welcomed the World Health Organization's publication of draft guidelines on biosimilar monoclonal antibody (MAb) products, but has expressed concern over what it calls 'major and undesirable divergences' between the draft and the existing EU and US guidelines, particularly in terms of the comparability concept and the clinical trial requirements for biosimilars.