Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?

The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs in the field of biotherapeutics has significantly evolved in recent years. In particular, monographs on complex biotherapeutics call for greater flexibility as a means of better addressing the structural complexity and naturally occurring heterogeneity of large biologicals, and of facilitating the use of novel technologies. This manuscript provides an overview of strategies to overcome the challenges of elaborating monographs on biotherapeutics, based on discussions with Ph. Eur. stakeholders. It describes the science-based approach to building flexibility into a public standard, discusses aspects related to the monograph lifecycle and underlines the paramount importance of stakeholder participation in the work of the Ph. Eur.