The role of generics and biosimilars in ensuring sustainability and accessibility

What is a major healthcare challenge in the local market and how can its impact be anticipated?

The reality we are facing is the rise of chronic diseases among a growing population with increasing life expectancy. The natural consequence is the rising demand for healthcare and medication which most likely will continue. So, more people require more - and sometimes more expensive - medicines. 

In Greece, this challenge becomes even more complex, as a significant decline is reported in public funding for health expenditure (%) compared to the EU. The industry is burdened with extremely high returns to the state which frequently threaten the availability of many pharmaceutical products. This pressure makes it challenging both for affordable solutions to survive in the market and innovative ones to enter it. Only if effective measures to rationalise spending are applied, in combination with a gradual strengthening of public financing, will it be possible to have a predictable and more sustainable environment with the containment or even reduction of mandatory returns.

There is a consensus that we need to work together, with a long-term view, to build strong foundations to meet the patient's needs and ensure their access to their medication in a sustainable economic environment. 

Generics & Biosimilars are certainly part of the solution. We are happy to hear the authorities’ intention to increase their adoption. This adoption is something that is monitored across geographies and serves as a measure of system sustainability. It enables savings to patients, payers and governments, while also providing widespread access to life-saving therapies, balancing pharmaceutical spending and freeing up funds for future innovation.

It is our role as an industry to bring these solutions. We count on authorities and policymakers to enable both the entrance and sustainability of these medicines while motivating their more extensive adoption. In our opinion, we need to approach this from multiple angles:

a) Expedited pricing and reimbursement process for generics and biosimilars’ entrance, 

b) data-driven policies, 

c) proper incentives to motivate the use of these products, and above all, open dialogue between health authorities and the industry with a long-term vision, 

d) sustainable net prices to ensure market availability of pharmaceutical products.

In any conversation, I believe that the key to finding common ground is always prioritising the patient in all strategies and actions, either as an industry or as a policymaker.

Biosimilars contribute to the sustainability of healthcare systems in Europe by treating more patients within the allocated budget. Biosimilars have generated approximately €28.2 billion in savings due to list price reductions between 2012 and 2023 in Europe, thereby contributing significantly to the sustainability of healthcare systems. The generics and biosimilars sector should be viewed as an approach that generates value and supports the healthcare system, not just as a cost-saving measure. Generics and biosimilars improve access, ensure financial sustainability, strengthen the supply chain and enhance patient outcomes.

We should not underestimate the importance of alternatives in a world of supply disruptions. The availability of generics and biosimilars plays a crucial role in ensuring a more resilient supply chain by increasing the number of alternatives. Medicine shortages are primarily associated with products supplied by fewer than five providers, accounting for nearly 70% of cases. This highlights the vital role that generics play in ensuring a secure supply by offering a wider range of treatment options.

Some usually smile when we say that generics and biosimilars also promote innovation. Innovation is, unfortunately, expensive. The savings generated by the introduction of generics create room for this spending. Innovation is important, and we want to play our role in enabling it.

Shifting from a transactional to a strategic, long-term relationship between health authorities and the industry is essential. They both share a common interest in ensuring sustainable patient access to treatments. Creating an economic framework that rewards healthy competition and flexibility in response to shifts in demand while ensuring quality standards will benefit everyone.

What successful models of integrated health policy and equity have been implemented in different countries or by Sandoz, and what can we learn from them?

There are several excellent examples. Spain is one that comes to mind. It is projected that the Spanish Health Care System will save a cumulative total of €12 billion by 2024 due to biosimilar implementation since 2007. Sweden offers another interesting case. Before the launch of biosimilars, supportive cancer care required consent from three physicians. Because of the reduction of the treatment costs due to biosimilar competition, the authorities relaxed the restrictions on prescribing, requiring consent from only one physician. This resulted in a 500% increased use of the treatment.

At Sandoz, our focus is on driving access to make a difference for patients, particularly through the development of biosimilar and generic medicines. We strongly believe that access to high-quality medicines should be available to all. This is why we prioritise bringing more affordable solutions to the system quickly and with high standards. As the leading supplier of off-patent medicines, which account for around 80% of medicines worldwide, we strive to make these medicines more affordable and accessible. Our products reach over 100 markets, providing more than 800 million patient treatments annually. This not only benefits patients but also contributes to freeing up resources for healthcare systems, resulting in a total social impact of our key medicines estimated at USD 400 billion per year worldwide coming from improved patient access to treatment. We support stronger healthcare systems by delivering affordable medicines. For instance, in 2023 alone, our products delivered over USD 18 billion in savings to US and EU healthcare systems through the provision of high-quality biosimilars and generics.

In line with our commitment to increasing patient access to biologics, we launched the Act4Biosimilars initiative. This initiative aims to accelerate the approvability, accessibility, acceptability and affordability of biosimilars, to increase global adoption by at least 30 percentage points in 30 countries by 2030. 

Looking forward, we are committed to making an even greater impact on affordable, sustainable, and high-quality healthcare for those who need it most. Our dedication to driving access remains at the core of our mission, and we will continue to innovate and address global healthcare challenges to create a better future for patients worldwide.