REPORT SUMMARY

As biosimilars continue to play an expanding role in European healthcare systems, it is increasingly important to understand not only the savings and access gains they generate, but also the market conditions required to maintain those benefits over time. IQVIA Institute published scorecards on the sustainability of biosimilar markets in 2018. This report aims to review this sustainability and how health care systems have evolved over time highlighting the positive levers and areas of development to ensure market sustainability for Biosimilars.

This report highlights the value of biosimilars and evaluates the structural determinants of biosimilar market sustainability across a diverse set of European countries through a standardized, multi-dimensional assessment framework. It examines sixteen metrics across eight categories—including pricing rules and dynamics, incentives, purchasing mechanisms, dispensing and supply, clinical guidelines and prescribing practices, competitive structure, and healthcare system performance—to identify the policy configurations that support or hinder long-term biosimilar viability.

KEY FINDINGS

• Biosimilars have generated ~€75 billion in savings and significantly expanded patient access across Europe, but sustaining these benefits depends on maintaining attractive and competitive market conditions.
• While delays in updating of clinical guidelines remain in some cases, clinical confidence in biosimilars is now well established; however, differences in pricing, procurement, and incentive structures are the primary drivers of variation in sustainability across countries.
• Markets that combine moderate or limited pricing pressure, multi-supplier procurement, and other incentives for biosimilar uptake can be more suited for stronger long-term sustainability, while those relying heavily on price compression and restrictive tenders risk reducing competition and increasing supply vulnerability.
• Aggressive policies such as mandatory price cuts, reference pricing, and clawbacks continue to be seen in several countries. While these mechanisms aim to ensure affordability and budget predictability, their cumulative interaction may unintentionally create downward price spirals, delay biosimilar entry, and discourage manufacturer participation.
• Single-winner tenders and price-only procurement models limit competition, while weak or inconsistent prescribing incentives reduce systematic biosimilar adoption in many countries. While there are examples of countries moving towards multi-winner models and broad tender categories, these remain the exception across Europe.
• With 24 major biologics losing exclusivity between 2025–2032, the ability of healthcare systems to capture future savings and expand access will depend on improving biosimilar market sustainability today.