Biosimilars knowledge gap needs addressing

EGA addressed around 250 delegates from 34 countries, including 63 authorities at its 12th International Biosimilar Medicines Conference, which was held in London, UK, on 3 April 2014.

Despite biosimilars having been on the market for almost eight years [1], two biosimilar TNF-alpha monoclonal antibody (mAb) biosimilars having been approved by the European Medicines Agency (EMA) [2] and biosimilars having generated more than 300 million patient days of real world clinical experience, there is still a widespread lack of understanding, misinterpretation and miscommunication about the biosimilar scientific concept and the benefits of biosimilars. EGA therefore called on delegates to put forward ideas and solutions to bridge the information gap on biosimilars.

It was highlighted that national authorities play a crucial role in reaching out to their national medical societies and ensuring that the biosimilar concept is fully understood. This includes creating a better understanding of the European Medicines Agency’s (EMA) scientific assessment and the European Commission’s (EC) approval of biosimilars in extrapolated indications.

Attention was drawn to the EC platform on ‘Access and uptake of biosimilars’ and the consensus document on ‘What you need to know about biosimilars’, which has been endorsed by European Member States. This document is an important source of knowledge, which could help in improving the understanding of the biosimilar concept. It explains what are biologicals and biosimilars, as well as how biologicals and biosimilars are regulated in Europe. Question and answer sections for patients, physicians and payers are also included.

A number of European medical societies have challenged the scientific assessment by EMA and the EC approval of biosimilars. The main reason for this appears to be due to the reduced trial data used to authorize biosimilars. Such positions, however, are considerably hampering the prescription of biosimilars and thereby undermining access to biologicals for patients. It was pointed out that running extra trials are unnecessary and unethical [3], and are contrary to the intent of what biosimilars are trying to achieve, i.e. a cheaper option. If they have to undergo the full clinical trial programme it would cost Euros 500 to Euros 800 million, which will affect their affordability. EGA held a dedicated session called ‘Biosimilars for doctors’, which hoped to address issues surrounding biosimilars and bring clarification by addressing a number of questions raised in the medical community.

The key priority of EGA is to reduce the gap in information and knowledge on biosimilars in order to build and consolidate trust and to continue to partner with healthcare actors on these issues in order to guarantee that biosimilars are able to deliver their full potential. The European Biosimilars Group of EGA is therefore calling upon European regulators and European Medical Societies to take an active role in informing their respective stakeholders about the stringent regulatory requirements that are in place to guarantee the safety, the quality and efficacy of all biologicals that are approved for marketing in Europe. In fact, EMA has already set up committees to provide further education on the regulatory process of biosimilars.

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References
1. GaBI Online – Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 18]. Available from:www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. Thorpe R, Wadhwa M. Biosimilar monoclonal antibodies approved for use in the EU. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(1):9. doi:10.5639/gabij.2014.0301.004
3. Schneider CK. The ethics of biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(1).6-7. doi:10.5639/gabij.2013.0201.001

Source: www.gabionline.net