Table 1.

Highlights.

What is already known about the topic?

The organization and implementation of tendering of off-patent biologicals and biosimilars varies across European Member States, regions and purchasing groups. The organization and design of tenders may play a key role in the evolving biosimilar market. It is not fully elucidated how tenders for off-patent biologicals and biosimilars are designed, and if approaches are aligned with sustaining market competition and societal savings for healthcare systems over the long term.

What does the paper add to existing knowledge?

This mixed methods study reports quantitative results derived from a survey among purchasers and hospital pharmacists regarding the application of tenders and qualitative insights from expert-interviews with suppliers and purchasers. This paper puts forth an actionable framework with proposals that could contribute towards a more sustainable organization and application of tenders for off-patent biological medicines and biosimilars in Europe.

What insights does the paper provide for informing health care-related decision-making

Findings may inform and support purchasers, suppliers and policymakers regarding the organization and optimization of tender procedures for off-patent biologicals and biosimilars. Tender procedures must aim to (i) ensure market plurality and (ii) include award criteria beyond price (warranted that criteria are objectively and transparently defined, scored and competitively rewarded). Depending on the market (maturity), additional actions are considered needed.

In this manuscript, the term “off-patent biologicals” refers to reference biologicals that lost patent protection and are exposed to competition from biosimilar alternatives.