Demonstrating biosimilarity in the EU

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Demonstrating biosimilarity in the EU

Home/Reports | Posted 09/12/2016 0 Post your comment

How has the European Medicines Agency (EMA) changed its requirements for biosimilars since it first approved biosimilars in 2006? This is a question raised by Dr Martina Weise, Head of the Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM).

Dr Weise discussed the biosimilars applications reviewed by EMA and the evolving landscape on data requirements to demonstrate biosimilarity in the European Union (EU) in her presentation at the 14th Annual Biosimilar Medicines Group Conference [1].

The EU was the first to establish a legal framework for biosimilars back in 2003 [2]. EMA first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006 [3]. Since those early days, EMA has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences.

Major changes in data requirements, according to Dr Weise, include the choice of the reference product, clearer requirements on quality data, changes in the focus for non-clinical studies, use of a tailored clinical programme, reduced clinical programme, extrapolation and pharmacovigilance.

The following series of five articles discuss biosimilars applications reviewed by EMA and the evolving landscape on data requirements to demonstrate biosimilarity in the EU.

Disclaimer
The author of the presentation [1] declared that the views and opinions expressed in the presentation were personal views, and may not be understood or quoted as being made on behalf of the Committee for Medicinal Products for Human Use (CHMP), or reflecting the position of the CHMP or any other EMA Committee or Working Party.

Editor’s comment
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If you would like to receive a PDF copy* of the Weise presentation [1], please send us an email.

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Tailored and reduced clinical programme for biosimilars

Changes in quality data and non-clinical studies for biosimilars

Changes in requirements for reference products for biosimilars

References
1. Weise M. Evolving landscape on data requirements to demonstrate biosimilarity – the EU perspective. 14th Annual Biosimilar Medicines Group Conference. 28–29 April 2016; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

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