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.
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.
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References
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
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