The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products

Abstract

European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs however faces considerable challenges in the current environment. This manuscript addresses what the main challenges are (complexity of biologicals, setting of specifications, relations with biosimilars) and how they are overcome.