Education, awareness, collaboration – the journey to increase biosimilar adoption in Europe

Biosimilars offer a beacon of hope for patients in many countries with little to no access to biologics. As successors to biological medicines for which the patent has expired and exclusivity has been lost (reference medicine), biosimilars are as safe and effective as their reference medicine.

Since their introduction in Europe in 2006, biosimilars have led to €30bn in cumulative savings for European healthcare systems. These savings can bring many benefits to patients, such as broad and early access to treatments and better healthcare services. However, while Europe has been a pioneer in the adoption of biosimilars, there is a gap in realising their potential across the region.

Many countries that are most in need of biosimilars are unable to access them. This challenge takes centre stage in the newly launched Act4Biosimilars Deep Dive Report for Europe, which explores opportunities to expand access to biologic medicines across the region. The report identifies the challenges to biosimilar adoption and the growing disparity between Eastern and Western Europe. The report complements the Action Plan, which offers strategies, tools and activities that can be used by stakeholders in any country, regardless of where it is on its biosimilar journey.

The ultimate goal of the initiative is to increase biosimilar adoption by at least 30% in 30+ countries by 2030 – a bold but achievable goal. In striving towards this goal, we can help transform the lives of more patients by enabling affordable access to life-changing, advanced medicines.

The Action Plan highlights the power of education, which can counteract biosimilar misinformation and disparagement, and drive informed decision-making, helping to increase adoption.

Despite the European Medicines Agency’s approval of biosimilars as interchangeable with reference medicines in the EU, biosimilar acceptance remains low, especially across Southern and Eastern Europe. One issue raised in the report is the scarcity of biosimilar information in native languages across Eastern European countries.

‘Education for all stakeholders is the catalyst for change, empowering individuals to make informed choices about their healthcare that are not fuelled by misconceptions’

This means physicians are missing out on vital information, including guidance on transitioning, available on national medicine agencies’ websites. This has led to a disparity in physicians’ knowledge and comfort level when prescribing biosimilars and it also impacts patients, who are unable to access materials in their own language.

This challenge is also evident in Latin America, in countries like Colombia, Ecuador and Chile. Bridging this knowledge gap with accessible materials for patients and healthcare professionals (HCPs) is an essential step to increasing biosimilar adoption.

When it comes to disparity in education on biosimilars, it’s not just an issue of location. As mentioned, different HCP specialists have a different understanding and comfort level with biosimilars. In this decade, more biosimilars will become available in new therapy areas and it is important that extensive biosimilar education programmes are put in place leading up to the biosimilars becoming available. It is vital that HCPs have all the necessary information that will able them to discuss biosimilars with their patients.

When HCPs are not educated on new therapies, it prevents patients from benefiting, as is seen in Italy, with over 130,000 patients with autoimmune conditions missing out on biological medicines, as awareness and educational materials have been limited. It is also crucial that patients have access to materials that make the complex topic of biosimilars understandable. However, this is not always the case. Misinformation and misconceptions can lead to further confusion, creating a barrier to greater adoption. HCPs play an important role in this. The treating physician, jointly in consultation with the patient, is best suited to make the decision to transition from the reference biologic to a biosimilar and between biosimilars. This should be based on patient profile, disease specification, clinical management and product features. Patients should be informed of treatment decisions and options and have their perspectives heard.

The biosimilars education project, run by Digestive Cancers Europe (DiCE), is a good example of education that stakeholders can take learnings from.

The project provides educational resources for patients and HCPs about biosimilars, including what biosimilars are, their benefits and the implications of transitioning to biosimilars for patients. One example focused on metastatic colorectal cancer, aspiring to improve education on biosimilars, enhance the role of patients in treatment decision-making processes and encourage communication between HCPs and patients.

By partnering with various stakeholders, DiCE has developed educational materials such as brochures, videos and a checklist for HCPs from which to answer patients’ frequently asked questions. Ensuring similar materials are available for all therapy areas and translated into local languages will be a big step towards improving the acceptability of biosimilars across Europe.

Unlocking the potential of biosimilars in Europe for patients begins with education for all. Collaboration is key to improving education, as all stakeholders have a role to play. By working together, we can make a difference.

Along with education, increasing biosimilar adoption requires a positive patient experience. A positive experience can instil confidence and trust in biosimilars, encouraging patients to accept biosimilar medicines. A key part of this is for patients to feel informed and heard by their HCPs.

This might mean HCPs taking the time to explain what biosimilars are or addressing patients’ concerns in plain, easy-to-understand language. Such experiences can also empower patients to feel that they can make informed decisions about their healthcare, as they feel more involved in the process.

With patient communities more connected than ever, positive experiences can help to support growing awareness and understanding of biosimilars. On the other hand, a poor experience, such as patients having their biologic medicine substituted at a pharmacy where they and their HCP are no longer involved in the treatment decision, can cause increased concerns and hesitancy, presenting another barrier to adoption.

The latest scientific evidence, including advancements in analytical characterisation studies, proves that biosimilars match their respective reference medicines in terms of quality, safety and efficacy. However, despite these advancements in analytical studies, it is still a requirement for biosimilars to undergo phase 3 clinical trials in Europe. This results in the process of developing biosimilars slowing down.

Streamlining this process has another important benefit – aside from safety, the patient experience should always be a key consideration when developing a medicine, meaning the burden for patients going through these clinical trials should be noted. These trials could potentially place patients under undue stress due to additional procedures, such as blood work and injections.

In doing so, patients may reflect negatively on their experiences with biosimilars, possibly perpetuating the fears and misconceptions surrounding them and hindering wide-scale adoption.

Prioritising the patient experience is critical to ensuring biosimilar acceptance. This should include taking time to explain biosimilars to patients and consult with them about their treatment decisions, and also to streamline biosimilar approval in Europe, including the requirements for phase 3 clinical trials, to avoid enrolling patients in unnecessary trials.

To realise the full potential of biosimilars in Europe, we must close the gap in understanding. Education for all stakeholders is the catalyst for change, empowering individuals to make informed choices about their healthcare that are not fuelled by misconceptions. By addressing the disparities in accessibility and acceptability of biosimilars, we can pave the way for a future where access to life-changing medicines is not limited to some, but is the reality for all.

Find out more about Act4Biosimilars at www.act4biosimilars.com/

References are available on request.