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Improving understanding of biotherapeutics and biosimilars Posted 21/09/2018

Additional information on biosimilars and biotherapeutics have been published in Europe.

On 13 September 2018, the European Medicines Agency (EMA) and the European Commission published new material, including an animated video for patients that explains key facts on biosimilars and how EMA works to ensure that they are as safe and effective as their reference biologicals. The video is available in eight European languages: Dutch, English, French, German, Italian, Polish, Portuguese and Spanish.

In addition, EMA published translations of the biosimilar guide for healthcare professionals into Dutch, French, German, Italian, Polish, Portuguese and Spanish. The guide, which was first made available in English in 2017 [1], provides healthcare professionals with comprehensive and easily understandable information on both the science and the regulation underpinning the use of biosimilars.

These newly published materials complement the Questions & Answers on Biosimilars for patients, which was published in 23 EU languages in 2017 [2].

On 29 June 2018, the European Directorate for the Quality of Medicines and Healthcare (EDQM) announced that it had published a new section dedicated to biotherapeutics on its website. The new biotherapeutics section on the EDQM website summarizes European Pharmacopoeia (Ph. Eur.) Commission activities and achievements in this field. In addition to clarification of the role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes the recently concluded P4-BIO pilot phase and the ongoing pilot phase on monoclonal antibodies (MAB pilot phase), explaining the strategy followed by the Ph. Eur. when setting requirements for the quality of this important class of biotherapeutics. It also describes various levels of flexibility integrated into Ph. Eur. texts, including those introduced recently to address the structural complexity, heterogeneity and compound diversity derived from different manufacturing processes of complex biotherapeutics.

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 [3].

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References
1.  GaBI Online - Generics and Biosimilars Initiative. Launch of biosimilars info for healthcare professionals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 21]. Available from: www.gabionline.net/Reports/Launch-of-biosimilars-info-for-healthcare-professionals
2.  GaBI Online - Generics and Biosimilars Initiative. EC publishes biosimilar Q&A document for patients in 23 languages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 21]. Available from: www.gabionline.net/Biosimilars/General/EC-publishes-biosimilar-Q-A-document-for-patients-in-23-languages
3.  GaBI Online - Generics and Biosimilars Initiative. The European Pharmacopoeia monographs for biotherapeutic products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 21]. Available from: www.gabionline.net/Biosimilars/Research/The-European-Pharmacopoeia-monographs-for-biotherapeutic-products

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Source: EDQM, EMA

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