Updates for European Pharmacopoeia monographs for biotherapeutic products

Biosimilars/Research | Posted 21/10/2022 post-comment0 Post your comment

The European Pharmacopoeia produces monographs for biotherapeutic products that are publicly available and considered the standard for defining the quality of these medicines. A recent study published in GaBI Journal [1] examines whether the challenges posed by complex products such as the introduction of biosimilars, have been met by new elements that have been added to the monographs.

20 AA010933

The monographs and associated physical reference standards of the European Pharmacopoeia play a major role in ensuring the quality of medicines in Europe, and across the globe. First created in the 1990s [2], the monographs have encountered difficulties related to the advent of biosimilars. As such, there has been a dialogue with stakeholders (including representatives from innovator and biosimilar companies, National Control Laboratories and licensing authorities) that is dynamic, collaborative and transparent, on the development of public standards for biotherapeutics.

The authors, based at the European Pharmacopoeia Department, European Directorate for the Quality of Medicines & HealthCare (EDQM), highlighted that the challenges were discussed at an international conference, ‘European Pharmacopoeia: tackling future challenges of the quality of medicines together’, in September 2016 in Tallinn, Estonia. Following the event, ways were proposed to identify and elucidate these challenges and determine how they can be overcome [2]. In addition, in 2019, there was a dedicated workshop at the International Conference, ‘EDQM and European Pharmacopoeia: state-of-the-art science for tomorrow’s medicines’ [3].

The authors note that EDQM has now taken action to improve communication methods to help ensure that the role played by monographs in defining quality standards for biotherapeutics is correctly understood. In addition, it has published a revised version of the Technical guide for the elaboration of monographs on synthetic peptides and recombinant DNA proteins [4] with the introduction of a new section on flexibility. The elements of additional flexibility are related to production, test procedures, acceptance criteria for quality attributes and reference preparations. The authors note that flexibility is required to address the structural complexity and process-dependent product heterogeneity of highly complex biotherapeutics such as glycoproteins (including monoclonal antibodies).

Following the revision of the guide, a number of monographs have been written and revised to better reflect the nature of biotherapeutics, including biosimilars. The authors note that although monographs based on a single product bring a lot of insight; a monograph based on many products can broaden the view, creating a robust standard and a firm foundation for the rationalization of test procedures in a multi-product setting.

GaBI Journal Citation Impact
2.2 – CiteScore 2021 (calculated on 5 May 2022)
2.4 – CiteScoreTracker 2022 (Last updated on 5 October 2022)

Submit a manuscript to GaBI Journal

Related articles
The European Pharmacopoeia monographs for biotherapeutic products

Non-biological complex drugs and pharmacopoeias

Microbiological control symposium: consensus on readiness of new methods emerges


The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.


Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


1. Buda M, Olga Kolaj-Robin O, Charton E. Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled? Generics and Biosimilars Initiative Journal (GaBI Journal). 2022;11(1):7-12. doi:10.5639/gabij.2022.1101.003
2. 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
3. Council of Europe. European Directorate for the Quality of Medicines & HealthCare, EDQM & European Pharmacopoeia: State-of-the-art science for tomorrow’s medicines, June 2019, Strasbourg, France. Workshop on biotherapeutics [homepage on the Internet]. [cited 2022 Oct 21]. Available from: https://www.edqm.eu/sites/default/files/medias/fichiers/Events/edqm_european_pharmacopoeia_state-of-the-art_science_for_tomorrows_medicines_-_workshop_on_biotherapeutics.pdf
4. Council of Europe. European Directorate for the Quality of Medicines & HealthCare. Technical guide for the elaboration of monographs on synthetic peptides and recombinant DNA proteins. 2018 [homepage on the Internet]. [cited 2022 Oct 21]. Available from https://www.edqm.eu/sites/default/files/medias/fichiers/European_Pharmacopoeia/Find_information_on/Technical_Guides/guide_ph_eur_synthetic_peptides_and_rdna_proteins_2018.pdf

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.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.


comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010