As
public standards for the quality of medicines in Europe, the monographs and
reference standards of the European Pharmacopoeia (Ph. Eur.) play a major role
in ensuring the quality of biotherapeutics, thereby contributing to overall patient
safety. By providing these recognised common standards for the quality of
medicines and their components, the Ph. Eur. promotes public health and ensures
the safety of medicines for patients. Ph. Eur. Standards are designed to meet
the needs of all stakeholders, including industry, Official Medicines Control
Laboratories (OMCLs) and regulatory authorities.
The
new biotherapeutics section on the EDQM website summarises Ph. Eur. Commission
activities and achievements in this field. In addition to clarification of the
role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes
the recently concluded P4-BIO pilot phase and the ongoing pilot phase on monoclonal
antibodies (“MAB pilot phase”), explaining the strategy followed by the Ph.
Eur. when setting requirements for the quality of this important class of
biotherapeutics. It also describes various levels of flexibility integrated
into Ph. Eur. texts, including those introduced recently to address the
structural complexity, heterogeneity and compound diversity derived from different
manufacturing processes of complex biotherapeutics.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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