OBJECTIVES: The market entry of biosimilars has represented a cost-reduction opportunity for healthcare systems across Europe. To seize this opportunity in the long term, systems’ rely on ensuring a sustainable competitive environment for all the market players. However, European experiences show that the level of competition generated by biosimilars varies by country, care setting and molecule. Biosimilars contribution to attaining price reductions and increased treatments’ access varies consequently. We aim to capture market dynamics for tumor necrosis factor (TNF)-alpha inhibitors in Southern Europe. The rationale behind this study is the need to gain an in- depth understanding on the impact of the competition generated by the availability of biosimilars in diverse market environments.

METHODS: This study is based on the quantitative analysis of market data (sales volume and NHS expenditure data) for TNF-alfa inhibitors and competing molecules in the immunology area.

RESULTS: Following TNF-alfa inhibitor biosimilars in Italian, Portuguese and Spanish markets, notable cost reductions have been generated for molecules directly exposed to biosimilars competition (i.e.. infliximab, etanercept and adalimumab). For these molecules, NHS costs in 2020 were lower than in previous years despite increased utilisation. However, the extent of cost-reductions attained is rather limited for on-patent molecules within the TNF-alfa inhibitors drug class, and for competing molecules in other therapeutic classes. This limitation becomes especially relevant in the context of observed prescribing shifts towards on-patent and less-affordable therapies, even after loss of exclusivities for Remicade, Enbrel, and Humira.

CONCLUSIONS: This study highlights the need for policies that do not only seek higher utilisation of ‘best-value’ TNF-alfa inhibitor biologics, but that also support the sustainable development of biosimilars for competing and still on-patent molecules in the immunology area.