The increasing cost of medicines was highlighted at the Biosimilar Medicines Group (formerly EBG) satellite symposium at the European Association of Hospital Pharmacists 2016 conference [1].
Using biosimilars as a way to reduce pharmaceutical expenditure was highlighted as a means to address this problem. However, the necessity of reducing the knowledge gap and building trust in biosimilars is still a key challenge.
Dr Paul Cornes (University Hospitals Bristol, NHS Foundation Trust, Bristol, UK) pointed out the fact that cancer medicine costs are increasing five times faster than any other class of medicine. Given the fact that by 2018, biologicals worth more than US$68 billion in current annual sales will lose patent protection [2], the case for using biosimilars seems clear.
Professor Arnold G Vulto (Erasmus University, Rotterdam, The Netherlands) highlighted the fact that the total medicine bill will grow exponentially with the introduction of so many blockbuster breakthrough medicines. He too pointed to the ‘savings potential of biosimilars medicines’. He suggests that one way to modify the increasing cost of medicine would be to increase the use of biosimilars.
Dr Niklas Ekman, a senior researcher at the Finnish Medicines Agency (FIMEA, Helsinki, Finland), gave a presentation on ‘Biosimilars from the perspective of an EU regulator’. He highlighted the fact that batch-to-batch variability is inherent for all biologicals, both for originators and biosimilars.
Dr Ekman also mentioned that FIMEA considers EU biosimilars interchangeable with their reference biologicals. Automatic substitution at the pharmacy level, however, is not included in the current FIMEA recommendation [3, 4]. He also pointed to similar positions that have been adopted by other EU national authorities, including the Medicines Evaluation Board (MEB) in The Netherlands, the Paul Ehrlich Institute (PEI) in Germany and the Health Products Regulatory Authority (HPRA) in Ireland.
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Saving money in the European healthcare systems with biosimilars
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References
1. Derbyshire M. Reducing healthcare costs and building trust in biosimilar medicines. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):84-8. doi:10.5639/gabij.2016.0502.020
2. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
3. GaBI Online – Generics and Biosimilars Initiative. Finnish drug regulator recommends interchangeability of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Policies-Legislation/Finnish-drug-regulator-recommends-interchangeability-ofbiosimilars
4. FIMEA. Interchangeability of biosimilars – position of Finnish Medicines Agency Fimea. 22 May 2015 [homepage on the Internet]. [cited 2016 Aug 5]. Available from: www.fi mea.fi /documents/542809/838272/29197_Biosimilaarien_vaihtokelpoisuus_EN.pdf
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