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More than 30 years ago, the introduction of biotechnologically manufactured medicines created a new class of pharmaceuticals, namely the biopharmaceuticals, or simply biologicals. In the year 2017, the top ten selling products of this class accounted for €16.5 billion worth of sales in Europe alone. The loss of exclusivity of such therapies provides the opportunity for other companies to manufacture and market the same product. A major hurdle in this concept is the fact that biological therapies are subject to an inherent degree of variability. This has multiple implications for the development and authorization of a biosimilar. As biosimilars provide a more cost-effective option compared to the reference product, their market access presents valuable cost-containments for national healthcare systems. The extent of a biosimilar’s market penetration depends on the policies that are implemented by national authorities. These policies differ greatly between European countries. The objective of this study is to evaluate which policies guarantee, and which policies obstruct the establishment of sustainable biosimilar markets in Europe. Methods that were used to achieve this goal consist of a search via the biomedical database ‘Embase’ in combination with grey literature obtained through Google Scholar. Search terms included 'biosimilar agent'/exp, 'reimbursement'/exp and 'Europe'/exp. Furthermore, an expert on the subject of this study was interviewed. The different policies implemented by Norway, Poland, Germany, the UK, Denmark and Belgium are presented. Accompanying these results, the approaches that experts recommend in order to increase the biosimilar market share are elaborated. These approaches include the establishment of a competitive and attractive market, together with the realization of extensive communication with, and education of stakeholders. Furthermore, the experts’ opinions on the implementation of incentives for prescription of biosimilars and substitution of biologicals by pharmacists is discussed. In conclusion, to realize the biosimilar’s cost-saving potential, the development of a market providing long-term sustainability for biosimilar manufacturers has to be prioritized over the immediate realization of savings. National authorities can achieve this goal by favoring demand-side policies over supply-side policies. This implies that practices such as mandatory price reductions or inclusion of biosimilars in reference systems should make way for educational initiatives and the incentivization of biosimilar prescription, potentially supported by prescription quotas. Moreover, tendering procedures should allow healthy competition between multiple manufacturers. Finally, although pharmacist substitution could strongly improve biosimilar uptake, the debate whether it should be permitted or not is yet to be resolved.
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