Abstract:
The monographs and associated physical reference standards of the European Pharmacopoeia (Ph. Eur.) are legally binding public standards in the member states of the European Pharmacopoeia Convention and thus play a major role in ensuring the quality of medicines in Europe – and beyond [1]. While Ph. Eur. monographs on biotherapeutics (covering active substances as well as medicinal products) have existed for nearly three decades, their elaboration has faced challenges in recent years. The difficulties encountered relate mostly to the advent of biosimilars and a misunderstanding of the role of monographs in this context. These challenges were discussed at the international conference entitled European Pharmacopoeia: tackling future challenges of the quality of medicines together in September 2016 in Tallinn, Estonia (hereinafter “the Tallinn conference”). Following the event, ways were proposed to identify and elucidate these challenges and determine how they can be overcome [2]. The dialogue with stakeholders on the development of public standards for biotherapeutics continued in June 2019 at the dedicated workshop of the International Conference entitled EDQM & European Pharmacopoeia: State-of-the-art science for tomorrow’s medicines held to mark the publication of the 10th Edition of the Ph. Eur. (hereinafter “the Strasbourg conference”) [3]. On the eve of the launch of the 11th Edition of the Ph. Eur. In 2022, this manuscript provides an overview of the key points that emerged from the discussions held with Ph. Eur. users, such as representatives from innovator and biosimilar companies, National Control Laboratories and licensing authorities. It also offers a status update on Ph. Eur. monographs in the field of biotherapeutics.

Subscribe now to GaBI Journal to view full information of this article to be published in the next journal issue.

This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.