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Switching approaches to biosimilars in Nordic countries

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In the European Union (EU), decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency (EMA), but at the national level. This is despite the fact that biosimilars developed in line with EU requirements are considered by EMA to be therapeutic alternatives to their reference biologicals.

Differences in the healthcare systems between different countries in Europe and differing attitudes have led to significant differences in the uptake of biosimilars between different countries. Automatic substitution of biosimilars is not routinely practised in Europe, although in some Member States the use of biosimilars has been actively facilitated by national and local tender systems [1].

The Nordic countries have been seen as leading the way when it comes to switching and substitution of biosimilars in Europe [2], but even within these countries there are differences in the way they approach switching to biosimilars, see Table 1.

Table 1: Switching recommendations in Nordic countries

Country	Switching recommendation	Financial incentives	Management involvement	Medicines agency involvement
Denmark	Switching recommended	Strong financial incentives	Strong management involvement	Drug authority initially passive regarding switching – now positive
Norway	Switching at discretion of hospitals/physicians	Strong financial incentives	Medium management involvement	Drug authority positive to switching
Sweden	Switching was not recommended	Strong financial incentives	Low management involvement	Drug authority negative to switching

Despite a reluctance to switch patients to biosimilars in many countries, financial pressures and the growing body of evidence supporting switching may change the tide in Europe in the near future. Support for switching from an originator to a biosimilar includes the NOR-SWITCH study [3] and the Danish infliximab switching study [4], as well as real-world switching data for the etanercept biosimilar Benepali [5].

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar substitution in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Reports/Biosimilar-substitution-in-Europe
2. Madsen S. Improving access to modern therapies: what can we learn from gainsharing practices? The Scandinavian experience. 15th Biosimilar Medicines Conference. Biosimilar medicines: a game changer for healthcare sustainability; 23−24 March 2017; London, UK.
3. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
4. GaBI Online - Generics and Biosimilars Initiative. Danish infliximab switching study shows no difference [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/Research/Danish-infliximab-switching-study-shows-no-difference
5. GaBI Online - Generics and Biosimilars Initiative. Real world switching data for etanercept biosimilar Benepali [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/Research/Real-world-switching-data-for-etanercept-biosimilar-Benepali

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