The European Pharmacopoeia monographs for biotherapeutic products

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European Pharmacopoeia (Ph. Eur.) monographs for biologicals 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 and the value and utility of these monographs have been questioned in recent years. What such challenges are and how they can be overcome is discussed by Head of Division of the European Pharmacopoeia Department at the EDQM, Dr Emmanuelle Charton, in a GaBI Journal paper [1].


Ph. Eur. is Europe’s official pharmacopoeia and is legally binding in 37 European countries, including the European Union (EU) Member States. It lays down common, compulsory quality standards for all medicinal products in Europe. In 2016, the European Directorate for the Quality of Medicines and Healthcare (EDQM) published the 9th Edition of the European Pharmacopoeia, which contains 2,343 monographs and 359 general texts and became legally binding on 1 January 2017 [2].

Ph. Eur. monographs are normally elaborated using a multi-source approach taking into account the specifications of more than one marketed product and with the collaboration of more than one manufacturer. This approach has raised concerns in industry that this establishes ‘a standard of inferior quality, without consideration of the criticality of quality attributes and preclinical/clinical evidence’. The EDQM considers, on the contrary, that ‘monographs in a multi-manufacturer situation have multiple advantages, since comparison of different products and procedures provides a forum for consensus and leads to the elaboration of more robust standards’.

The EDQM does, however, admit that elaboration of monographs for biologicals can be challenging. Complexity of the molecules, which tests to include and the advent of biosimilars were all identified as challenges to be overcome.

Despite the challenges, Dr Emmanuelle Charton states that ‘individual monographs play a major role in ensuring that medicinal products throughout Europe meet the same quality standards, thereby contributing to patient safety’.

Editor’s comment
This article for GaBI Online is a summary of the full article published in GaBI Journal.

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Readers interested to learn more about pharmacopoeias are invited to visit to view the following manuscript published in GaBI Journal:

Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias

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1. Charton E. The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):174-9. doi:10.5639/gabij.2016.0504.045
2. Borchard G. Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(1):36-41. doi:10.5639/gabij.2016.0501.009

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