On 29 October 2014, the European Medicines Agency (EMA) published the new version of its overarching biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products.
The guideline outlines the general principles to be applied for biosimilars and describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles for establishing biosimilarity.
The main change brought by this new guidance is the possibility for biosimilars developers to use a comparator authorized outside the European Economic Area (EEA) during the clinical investigation of a biosimilar. This new concept is expected to facilitate the global development of biosimilars and to avoid unnecessary repetition of clinical trials.
The change in the guidance reflects the European Commission’s confirmation that it intends to accept batches of reference medicines sourced from outside the EEA. Before this change biosimilars’ manufacturers were required to identify a reference medicine that is or has been authorized in the EEA and whose batches are sourced from within the EEA [2].
The change is expected to give significant savings for biosimilars’ manufacturers, as trials conducted elsewhere, using other reference products, may now be used for the EU filing, whereas in the past these trials would have had to be repeated in European patients, using an EU-approved reference product [2].
The guideline also introduces a scientific definition of a biosimilar:
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product) in the EEA. Similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise needs to be established.
The guideline replaces EMA’s ‘Guideline on similar biological medicinal products’ (CHMP/437/04).
Guideline on similar biological medicinal products
Effective date: 30 April 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf
Although the guideline will only come into effect on 30 April 2015, EMA states that applicants can apply some or all provisions of the guideline already now.
EMA published the new version of its biosimilars quality guideline on 26 June 2014 [1] and is also revising another of its overarching guidelines for biosimilars:
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Date: 3 June 2013
End of consultation (deadline for comments): 30 November 2013
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf
Related articles
Revision of guideline on clinical and non-clinical issues for biosimilars
EMA issues draft revision of overarching biosimilar guidelines
EU guidelines for biosimilars
References
1. GaBI Online - Generics and Biosimilars Initiative. EMA issues revised version of biosimilars quality guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 7]. Available from: www.gabionline.net/Guidelines/EMA-issues-revised-version-of-biosimilars-quality-guideline
2. GaBI Online - Generics and Biosimilars Initiative. EMA to accept biosimilar reference medicines from outside EEA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 7]. Available from: www.gabionline.net/Guidelines/EMA-to-accept-biosimilar-reference-medicines-from-outside-EEA
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