Urgent policy action is needed to avoid a €15 billion miss in healthcare savings
Over the past two decades, biosimilar medicines have become a cornerstone of affordable healthcare in Europe, driving down costs while expanding access to critical biologic therapies. But a new report from IQVIA warns of a looming crisis: the so-called “biosimilar void.”
According to the white paper, nearly €30 billion worth of biologic medicines will lose market exclusivity in Europe by 2032. However, the pipeline of biosimilars is thinning fast. IQVIA estimates that nearly half of these medicines may not face biosimilar competition at all. If this gap persists, Europe’s healthcare providers could lose out on an estimated €15 billion in potential savings.
The quiet decline of a cost-saving system
The drop-off is striking. Between 2021 and 2023, only €4.3 billion worth of biologics faced biosimilar competition, a sharp 45% decrease compared to the prior three years. Looking ahead, the report projects that while 110 biologics are set to lose patent protection by 2032, only a small fraction—especially among low-sales and orphan drugs—are attracting biosimilar interest.
“The pipeline is narrowing significantly,” IQVIA’s analysis notes. In fact, the average number of biosimilars in development per molecule is expected to drop from 2.19 for products losing exclusivity between 2023 and 2027 to just 0.43 between 2028 and 2032.
This decline isn’t due to a lack of need. The report argues that demand for biologics, especially in oncology, immunology, and rare diseases, is expected to grow. But development is being stifled by high upfront costs, regulatory complexity, and limited commercial viability for certain products. Smaller market sizes, particularly for low-sales or orphan drugs, make it difficult for biosimilar developers to justify the investment.
High-value opportunities are being missed
Perhaps most telling is that even high-sales products are slipping through the cracks. Of the 26 biologics with annual sales over €500 million and upcoming loss of exclusivity, nearly 30% have no biosimilars in development. That’s nearly €8 billion in annual drug spending potentially left untouched by competition.
Moreover, the vast majority of biologics set to lose protection (76%) are lower-sales products. Only 7% of these have a biosimilar in the works. These may not be blockbuster drugs, but collectively they account for about €7 billion in spending—savings that could be reinvested elsewhere in stretched health systems.
Removing obstacles for biosimilars
If Europe wants to avoid this biosimilar void, the solution isn’t just more investment: it’s smarter policy.
IQVIA outlines a set of targeted reforms. Among them: streamlining regulatory pathways across the EU, encouraging earlier scientific advice for developers, and making pricing and reimbursement mechanisms more predictable and transparent. Without such changes, developers may continue to focus on the few lucrative molecules while leaving broader public health savings on the table.
Julie Marechal-Jamil, Director of Biosimilar Policy & Science at Medicines for Europe, echoed these concerns: “So far, biosimilar medicines have delivered huge access benefits for patients and savings for healthcare budgets. We need to jump start the multistakeholder policy process ensuring more biosimilar medicines development and access, as patient demand for biological medicines increases.”
The report makes clear that without proactive policy measures, Europe risks undermining its own ambitions for sustainable healthcare. The opportunity is not just to save money—it’s to secure access for millions of patients and to maintain competitive pressure on prices at a time when health budgets are under extreme pressure.
A crossroads for healthcare access
The biosimilar success story in Europe isn’t over, but it’s at a turning point. Either we act now to maintain a robust, competitive market for these essential medicines, or we allow short-term inefficiencies to create long-term human and financial costs.
As experts and advocates for biosimilar development, we will continue to push, and we urge other industry players, along with regulators and policymakers to come together to bridge the biosimilar gap—before it becomes a void.
