The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928).
The Ph. Eur. Commission embarked upon the setting of public standards for therapeutic monoclonal antibodies (mAbs) in 2014 with a pilot phase and following extensive consultation with its stakeholders. A ‘bottom-up’ approach has been undertaken, that started with an investigation of the feasibility of establishing individual monographs (using Infliximab as a case study), building on knowledge and exploring areas for the development of general Ph. Eur. texts applicable to mAbs.