Dr Richardson confirmed that biosimilars have the same safety and efficacy as originator biologicals and that to date there have been no safety issues reported to EMA concerning biosimilars approved in Europe.

The reason to have biosimilars is to reduce the cost for life-saving medicines; however, the uptake of biosimilars in Europe has been slower than expected. The report produced by the EC’s Enterprise and Industry Directorate-General [2] does, however, show that there is price competition and that some countries are more proactive in promoting biosimilars than others.

The EC report looks at the market issues surrounding biosimilars and was produced in order to provide a better platform for communication around biosimilars and to put to rest unfounded fears surrounding the safety and efficacy of biosimilars. The report also discusses whether substitution of biosimilars might be an option for European countries in the future.

Biosimilars provide savings of around 30% compared to the originator biological. Although this is modest compared to generics, which typically provide savings of 70–80%, biologicals are generally much more expensive than small molecule drugs and therefore the savings are still significant.

European sales of biologicals in 2011 were Euros 2.3 billion. Sales of biosimilars during the same period were Euros 239 million or 11% of the market.

Related articles

International harmonization for biosimilars

Biosimilar monoclonal antibodies and pharmacovigilance in Europe

Possibility of substitution of biosimilars in Europe

Use of biosimilars in Europe

References

1.  GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars  

2.  European Commission, Enterprise and Industry Directorate-General. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. 2013 [cited 2013 Jun 7].

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.