In 2014, some 245 biologicals had been authorized in the European Union (EU) and the US, representing 166 different active substances. Over 300 are being investigated in clinical trials. In 2014, worldwide sales of biologicals were almost US$200 billion. In Europe, seven out of 10 of the most sold medicines in 2014 were biologicals. Once patents on originator biologicals have expired biosimilars can be manufactured and marketed.

In a similar way to the emergence of generics, biosimilars offer a major opportunity to provide greater access to affordable health care. The benefits that biosimilars can offer to patients in particular are discussed in the handbook.

Patients
Patients in the EU have already benefited from the availability of biologicals for more than 30 years. Although these medicines have revolutionized treatment of many life-threatening diseases, they are expensive and often beyond the means of many patients. Since 2006, when the European Medicines Agency (EMA) finalized guidelines for biosimilars, the agency has approved 20 biosimilars for use in the EU [1].

The potential savings which can be expected by the introduction of biosimilars into EU health care are likely to result in more patients having access to the medicines that they require. Furthermore, patients can be confident that these products are assessed and approved for use in Europe by the same scientific authorities that approved their predecessors, i.e. the reference products.

Biosimilars penetration in Europe, however, has been found to vary significantly between different countries. This has been attributed to differences in the healthcare systems between different countries to differing attitudes in different countries [2].

Related article
Medicines for Europe launches Biosimilars Handbook

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars penetration in Europe varies widely [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Reports/Biosimilars-penetration-in-Europe-varies-widely

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