EMA to revise overarching biosimilar guidelines

INICIO/Directrices | Posted 09/12/2011 post-comment0 Post your comment

EMA announced on 17 November 2011 that it has published a concept paper asking for comments on topics to be included in a revision of the agency’s 2005 overarching guideline on similar biological medicinal products. The paper will be released for a three-month consultation period.


EMA wants to update its overarching guideline on biosimilar drugs to reflect the growing complexity of biosimilar products and unique issues concerning their development.

Since the original overarching biosimilars guideline came into effect in October 2005 several biosimilar products have come onto the EU market, the number of scientific advices given by EMA’s Committee for Human Medicinal Products on the development of biosimilar products has increased significantly, and the regulatory framework is becoming wider, e.g. addition of the guideline for biosimilar monoclonal antibodies [1].

Therefore, due to the development of more complex biosimilars, EMA has proposed a list of several topics for re-evaluation. These include:

  • explaining the principles of biosimilarity in a clearer way
  • defining the term ‘biosimilar’ more clearly (numerous terms are in use for ‘biosimilar’ or ‘similar biological medicinal product’, and often the term ‘biosimilar’ has been used in an inappropriate way)
  • discussion of the feasibility of following the generic legal basis for some biological products
  • re-discussion and potential refinement of some more specific aspects, e.g. should discussion of equivalency of safety and efficacy not be covered by the revision of the general non-clinical and clinical guideline [2]. Further discussion is needed to clarify if in exceptional situations, e.g. where a very simple biological fully characterised on the quality level, a biological medicinal product could be authorised based on a bioequivalence study only combined with an extensive quality comparability exercise.

The concept paper seeks stakeholders’ views on the need to revise the 2005 guideline and is available on the EMA website.

The proposed guideline will replace the ‘guideline on similar biological medicinal products (CHMP/437/04)’.

Feedback for the concept paper can be submitted until the end of February 2012. EMA expects a draft revised guideline to be released in the first quarter of 2012.

Concept paper on the revision of the guideline on similar biological medicinal product
Date: 17 November 2011

Related article

EU guidelines for biosimilars


1. GaBI Online - Generics and Biosimilars Initiative. EMA adopts guideline on biosimilar monoclonal antibodies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 09]. Available from: www.gabionline.net/Guidelines/EMA-adopts-guideline-on-biosimilar-monoclonal-antibodies

2. GaBI Online - Generics and Biosimilars Initiative. EMA plans to revise biosimilar guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 09]. Available from: www.gabionline.net/Biosimilars/News/EMA-plans-to-revise-biosimilar-guidelines

Source: EMA

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