A biosimilar drug is a biological medicinal product that is developed to be highly similar to an existing biological medicinal product (“reference” or “original”).1 Its development is based on existing scientific knowledge and on an exhaustive comparability exercise with the reference biological drug. It is therefore not necessary to repeat all the clinical studies conducted with the original biological medicinal product, which results in a reduction in costs.1
This also means that biosimilar medicinal products are normally offered at a lower price than reference biological drugs. The actual difference in price varies from country to country and between molecules. In Spain, there is generally an average discount of 30% applied to biosimilars.2
It is estimated that biological medicinal products currently represent 27% of the value of total drug sales in Europe, largely thanks to monoclonal antibodies.3
In 2011, biological drugs accounted for a total expenditure of €2,800 million Euros in Spain, representing 30% of the overall expenditure in the Spanish National Health System (SNS, Sistema Nacional de Salud), and 46% of hospital spending on drugs. Furthermore, an upward trend is expected in the future.4,5
In the five most important countries in the EU, the accumulated cost from the eight most relevants original biological products is expected to reach 47,000 million Euros between 2016 and 2020.6
The cumulative savings over the next five years due to the use of biosimilars in these countries, adding USA, could range from 49,000 million and 98,000 million Euros. 7
Biosimilar medicines provide a major opportunity for costs savings, significantly contributing to the sustainability of national health systems while improving patients’ access to other medical innovations. However, for these benefits to take place, it is imperative that the biosimilar medicinal product market remains sustainable.8
The future of biological drugs is very promising9. It is expected that around 30% of the more than 940 new active substances introduced between 1996 and 2020 are/will be biological10. Currently, more than 700 biosimilars are in different stages of development worldwide, and will be ready in the coming years11.
These innovations will provide patients and clinicians with new treatment options, but their cost will be a challenge for the sustainability of healthcare systems. In this context, biosimilars can play a substantial role, providing more therapeutic options and contributing to improving efficiency12. This is the point where mAbxience can facilitate accessibility to different treatments, contributing to the sustainability of health systems.
- European Medicines Agency (EMA). Biosimilar medicines [Internet]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp
- Rovira J, Espín J, García L, Olry de Labry A. The impact of biosimilars’ entry in the EU market. Andal. Sch Pub Health. 2011;30:1–83.
- IMS Institute for Hethcare Informatics. Assessing biosimilar uptake and competition in European markets [Internet]. 2014. Available from: http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Assessing_biosimilar_uptake_and_competition_in_European_markets.pdf
- Mestre-Ferrandiz J. The Economics of Innovation and Incentives for Encouraging Medical R&D [Internet] 2014. Available from: http://www.slideshare.net/OHENews/antibiotics-and-the-economics-of-innovation
- Ruíz-Tagle J. España abrirá sus puertas a los biosimilares en un lustro [Internet]. 2012 [cited 2017 Mar7]. Available from: http://www.elglobal.net/hemeroteca/espana-abrira-sus-puertas-a-los-biosimilares-enun-lustro-OFEG_606008
- Delivering on the Potential of Biosimilar Medicines. Report by the IMS Institute for Healthcare Informatics March 2016
- IMS Health, MIDAS, IMS Health Market Prognosis; IMS Institute for Healthcare Informatics, Dec 2015
- Factors Supporting a Sustainable European Biosimilar Medicines Market. Market access report GFK. 2014
- PhRMA. Biologics Overview. Medicines in Development. Report [Internet]. 2013. Available from: http://phrma-docs.phrma.org/sites/default/files/pdf/biologicsoverview2013.pdf
- IMS Institute for Healthcare Informatics. Delivering on the potential of biosimilar medicines. The role of functioning competitive markets [Internet]. 2016. Available from: https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf
- Reinke, T. Biosimilars: The Pipeline Seams Seem To Be Bursting [Internet]. Manag. Care Mag. Online.2017 [cited 2017 Mar 27]. Available from: https://www.managedcaremag.com/archives/2017/3/biosimilarspipeline-seams-seem-be-bursting
- La introducción de los biosimilares en España. Estimación del ahorro para el Sistema Nacional de Salud Fundación Documento de trabajo 02/2017 Autores Almudena González, Yoana Ivanova,Néboa Zozaya, Margarita Jiménez, Álvaro Hidalgo.