Biosimilars: a vital remedy for Europe’s healthcare challenges

Since the first biosimilar approval in Europe twenty years ago, biosimilars have provided 6.9 billion patient treatment days and now provide 12% of the total volume of biologic treatments in Europe. The real-world impact behind these numbers is transformative.  

With chronic conditions, including cancer, diabetes, and immunology, surging across the continent, the financial burden on health systems has reached a tipping point that could threaten both patient care quality and system viability. The human cost extends far beyond those directly affected, creating ripple effects through families, workplaces, and entire economies. 

Chronic disease now affects one in four working-age Europeans, a reality largely driven by the continent’s ageing population. Projections show that Europeans are not getting any younger either, with the EU-27’s population aged 65 and above set to increase by 50% before the end of this century.  

Specific disease categories reveal even more troubling trajectories. Adult diabetes diagnoses have nearly doubled across Europe in just twenty years. Cancer struck 2.74 million new patients in 2022 alone. Meanwhile, autoimmune conditions continue to rise, with rheumatoid arthritis, for example, currently affecting two million Europeans.

Biosimilars: a key part of the puzzle

Fortunately, biosimilars represent effective treatment options for many of these conditions while also helping to support the sustainability of healthcare systems. Biosimilars are rigorously produced and tested, and meet the same exacting regulatory requirements, safety profiles, and quality standards as their reference biologics while offering the potential for significant cost savings. They can be made available to patients after original biologics lose patent exclusivity, representing a practical pathway to broader treatment access.

The market dynamics following biosimilar introduction consistently demonstrate their value, often driving down overall treatment costs through competition while simultaneously expanding patient access. This dual benefit supports the financial sustainability of healthcare systems while advancing equitable care.

Unlocking resources for healthcare systems in Europe through biosimilars

Biologics now make up a staggering 40% of Europe’s pharmaceutical spending, but savings from biosimilars can turn some of this cost burden into an opportunity for reinvestment in patient care. The financial impact of biosimilars has exceeded even optimistic projections. Between 2016 and 2021, cumulative savings from biosimilar competition doubled every two years across Europe, reaching €56 billion as of 2024. These savings can be used to increase access to affordable biologics and enable investment in other critical areas, whether this is additional infusion chairs, more nursing staff, or expanded treatment programs.

The opportunity ahead is even greater. By 2030, 69 biological medicines will lose exclusivity in Europe, double the number from the previous seven years. IQVIA estimates this represents a €28 billion savings opportunity between 2024 and 2030. This isn’t just cost reduction; it’s strategic reinvestment. Healthcare systems can channel savings into funding earlier screening programs, multidisciplinary care teams, and complementary services that enhance treatment effectiveness.

Rethinking current models

While much progress has been made, the full potential of biosimilars has not been realised. Greater transparency around biosimilar savings and their reinvestment could accelerate adoption across Europe. British Columbia in Canada offers a compelling model, publishing detailed savings reports that document precisely how biosimilar-generated funds flow back into healthcare improvements. This visibility creates a powerful feedback loop: when stakeholders can directly observe savings translating into expanded drug access, additional treatment capacity, or enhanced staffing levels, the case for biosimilar adoption becomes undeniable.

Gain-shares represent another underutilised tool for market advancement. This rewards healthcare institutions for undertaking the operational shifts required for biosimilar transitions, from staff education to workflow adjustments, by allowing them to retain a portion of generated savings for reinvestment at the institutional level. The UK, France, Ireland, and Canada have successfully implemented such frameworks, and there is great potential for other markets to reap similar rewards.

Regulatory reform is also needed. Several years of experience across a diverse range of molecules and therapeutic areas have taught us that biosimilars are a safe and effective alternative to biologics across Europe. The proof is in the millions of patients that have benefited from their use. This real-world evidence base creates a clear case for streamlining the approval process for new biosimilar molecules.

In fact, the EMA has recently published a reflection paper aiming to streamline the clinical development of biosimilars to waive phase III trials, in certain cases. This shift could play a pivotal role in accelerating access to biosimilars, while maintaining the highest standards of safety and efficacy.

Building bridges for better healthcare

Beyond the economics, maximising biosimilars adoption is a moral imperative, fostering equitable healthcare access across the continent. With strong adoption rates, European nations can simultaneously strengthen their healthcare systems’ financial foundations while delivering better patient outcomes.

The path forward demands not just recognition of this potential, but coordinated action to realise it. Success hinges on multi-stakeholder engagement throughout the biosimilars value chain. Industry leaders like Biocon Biologics play a pivotal role in partnering with national health systems to facilitate seamless integration of biosimilars into treatment pathways, while providing robust support for clinicians, pharmacists, and patients navigating the transition.

Meanwhile, policymakers and pharmaceutical companies must jointly champion comprehensive education initiatives that build confidence and understanding among both prescribers and patients. This collective approach, bringing together government, industry, healthcare professionals, and patient advocates can transform the biosimilars opportunity into lasting change and create healthcare systems that are both financially resilient and universally accessible. The stakes are clear – biosimilars offer a unique opportunity to advance sustainable, equitable healthcare for all.

At Biocon Biologics, we believe biosimilars are strategic enablers of resilient and inclusive healthcare. Expanding access to life-changing medicines is our primary mission. Through our integrated “Lab-to-Patient” model and a presence in over 120 countries, we ensure that life-changing medicines reach those who need them most. We currently deliver nine biosimilars across key therapeutic areas, including oncology, immunology, diabetes, and ophthalmology. At Biocon Biologics, we are not just making medicines. We are transforming lives and transforming healthcare.

For more information on Biocon Biologics, visit our website.