OBJECTIVES

Biosimilars offer the potential for €2 billion of savings annually across the EU. To facilitate biosimilar uptake, several mechanisms aimed at reducing the acquisition cost of biosimilars and encouraging biosimilar uptake have been implemented. However, the mechanisms used vary across the EU and it is unclear which mechanisms contribute towards a sustainable biosimilar marketplace.

METHODS

Using publicly available information combined with stakeholder interviews across the EU5, the biosimilar pricing, reimbursement, tendering, adoption and switching mechanisms for each market were identified and catalogued as either positive, neutral or negative towards biosimilar sustainability. The similarities and differences across the EU5 were then determined to identify which mechanisms contribute towards a sustainable biosimilar marketplace.

RESULTS

Whilst all EU5 countries have pricing measures in place, either through mandatory price discounts (France, Italy or Spain) and/or tenders (all EU5 countries), there is significant variation in the adoption and switching mechanisms between countries, which have the potential to create a more sustainable biosimilar marketplace. For example, all EU5 countries have biosimilar prescription targets in place, although with differing levels of enforcement. With exception of Spain, the other EU5 countries have gainshare mechanisms in place. None of the EU5 countries have pharmacist incentives in place, with four countries having some form of physician incentives and only two countries (Germany and Spain) having patient incentives in place to encourage switching to biosimilars.

CONCLUSIONS

To enable a sustainable biosimilar marketplace our analysis has identified four initiatives to be considered. (1) A fair price level avoiding significant mandated discounting for biosimilars or originators. (2) Procurement practices avoiding centralised, price-driven, single-winner-based tendering systems. (3) Physician and patient educational programs in place to facilitate biosimilar uptake. (4) Switching both treatment-naïve and continuing patients permitted and actively encouraged.