Medicines for Europe has published a comprehensive position paper outlining critical reforms needed in the European Biotech Act to address what it describes as a growing ‘biosimilar void’ threatening patient access, healthcare sustainability, and Europe's strategic autonomy in biotechnology.
The biosimilar sector, which Europe pioneered in 2006, has become a strategic pillar for the region's biotech hub, delivering significant economic and access benefits. According to the position paper, biosimilars have enabled 9.2 billion patient treatment days since 2011 across more than 10 therapeutic areas, including oncology, immunology, and rare diseases. In Poland, biosimilar trastuzumab increased breast cancer treatment access by 50%, while anti-TNF biosimilars expanded access to rheumatoid arthritis treatments sixfold in Austria. The sector supports 81,000 jobs in Europe, contributes €25.6 billion to GDP, and has generated €75 billion in healthcare savings, including €13 billion in 2024 alone.
However, Medicines for Europe warns that the ecosystem is at a breaking point. Currently, fewer than 30% of biologicals losing exclusivity have biosimilars in development, and by 2032, seven out of 10 biologicalmedicines facing loss of exclusivity may see no competition. Investment is further threatened by outdated regulatory processes, with only 46% of biosimilars used in Europe manufactured domestically, while 54% are sourced from Asia.
Key recommendations across four pillars
Manufacturing and R&D investment: The association calls for increased European Union (EU) funding for biotech manufacturing, simplified access to funding instruments, and the creation of coordinated ‘Biotech Centres of Excellence’ across Europe, replicating successful models like Slovenia's Biotech Hills and Poland's national biotechnology strategy.
Regulatory reform: A central demand is the waiver of comparative efficacy studies (CES) in official guidelines [1], recognizing their limited scientific added value and significant cost burden—representing 10-50% of total development costs. Medicines for Europe also advocates for acceptance of foreign-source comparators without additional three-way pharmacokinetic studies, and early guideline development for next-generation biotechnologies.
Intellectual property framework: The association strongly opposes the proposed one-year Supplementary Protection Certificate (SPC) extension in the Biotech Act, which it argues would cost healthcare systems €7.7 billion for just three top biologicals and fail to stimulate additional R&D investment. Instead, it recommends improving the SPC manufacturing waiver by allowing production throughout SPC protection and deleting unlawful notification systems that enable frivolous litigation. Harmonisation of EU IP provisions, including the Bolar exemption and patent-linkage prohibitions, is also prioritised to ensure timely ‘Day 1’ market entry.
Skills and talent development: The paper highlights a growing global talent war and fragmented European skills pipeline. Recommendations include strengthening STEM education, reinforcing the Pact for Skills, creating regional training hubs modelled on Ireland's NIBRT, and removing cross-border talent mobility barriers.
Medicines for Europe emphasises that without urgent action, Europe risks losing its leadership in biosimilar medicines at a time of rising global competition from China [2], India, Japan, South Korea, and the US. The association stresses that the Biotech Act must not simply extend monopolies but instead create conditions that reward actual investment in European manufacturing and innovation.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA adopts landmark reflection paper on tailored clinical approach for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 4]. Available from: www.gabionline.net/guidelines/ema-adopts-landmark-reflection-paper-on-tailored-clinical-approach-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. China now accounts for 20% of global drug development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 4]. Available from: www.gabionline.net/reports/china-now-accounts-for-20-of-global-drug-development
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