OBJECTIVES : With the increasing availability of biosimilars across Europe and product classes, this study aims to identify learnings regarding tender practices for off-patent biologicals and biosimilars and propose recommendations towards more sustainable practices.

METHODS : Semi-structured interviews were conducted with hospital pharmacists, purchasers and industry, including both the demand- and supply side perspective on tendering. Participants were recruited across seven European countries, representing different tender organization levels (Norway, Denmark, Italy, UK, France, the Netherlands, Belgium). Additionally, experts from European organizations were interviewed to include pan-European learnings.

RESULTS : In total, 28 semi-structured interviews were conducted. Across the board, it was recognized that current tender approaches might negatively affect market dynamics for off-patent biologicals and biosimilars, signalling the need for action by policymakers and purchasers to optimize tender processes, considering a more long-term strategic view. The higher than anticipated price erosions and existence of originator favoring tender practices (e.g. delayed tender opening due to contracts with originator, award criteria that favor the originator), limiting timely competition from and market opportunity for biosimilar suppliers, were identified as elements that could decrease competition over time. Generally, it was argued that tender procedures must aim to: (i) ensure market plurality (opportunity for multiple suppliers to win via multi-winner tenders or dividing market volume in multiple single-winner opportunities) and (ii) include award criteria beyond price only (warranted that criteria are objectively and transparently defined, scored and competitively rewarded). Depending on the market (maturity), additional actions were considered needed, such as active monitoring of the correct application of tender procedures. In addition, best-tender practices were identified from certain countries and regions, which could be used as example for other jurisdictions.

CONCLUSIONS : This study argues in favor of developing a more long-term strategic approach on tendering procedures for off-patent biologicals and biosimilars, identifying measures to optimize current procedures.