The European Pharmacopoeia monographs for biotherapeutic products

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

The European Pharmacopoeia monographs for biotherapeutic products

Biosimilars/Research | Posted 31/03/2017 0 Post your comment

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.

If you would like to receive a copy of the GaBI Journal article, please send us an email.

Readers interested to learn more about pharmacopoeias are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

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

If you are interested in contributing a research article in a similar area to the GaBI Journal, please send us your submission here.

References
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.