Biosimilar Medicines Today

Biosimilar medicines were invented in Europe 20 years ago to address the pressing need for better access to biopharmaceuticals in Europe. For example, a recent study demonstrated the inequity in access to biologic medicines for treatment of rheumatoid arthritis because lower income countries in Europe cannot afford such therapies.1 However even within high-income countries such as Germany and the UK, only 10-14% of patients with rheumatoid arthritis received treatment with biologic medicines.2 Considerable benefit awaits those patients who will gain access to treatment with biologic medicines in both low and high income EU countries thanks to the arrival of biosimilar medicines competition.

Through sophisticated new technology, our industry was able to deliver a global first with the first biosimilar medicine approved in 2006. Since that time, our industry has continued to invest substantially in new innovation, bringing the total number of biosimilar medicines available today on the European market to 20.3

1 Putrik et al. Ann Rheum Dis 2014;73:198-206
2 Rheumatoid Arthritis (RA) Market Forecast 2012
3 European Commission – Community Register

Patients & Quality

Our experience to date shows that biosimilar medicines significantly increase patient access to high quality treatments. Not only can more patients become eligible for treatment, they can also be used earlier in the treatment course, therefore enabling patients to live with better life quality standards. This is what happened in 2006 with the introduction of biosimilar filgrastim, which is used for neutropenia to support the immune system of patients under chemotherapy treatment. Between 2006 and 2013, biosimilar filgrastim ensured that 44% more patients obtained access to gold standard medicines in the EU-5 countries.4 Also for other therapeutic areas such as EPO or growth hormone, access increased considerably upon biosimilar competition and some countries were able to address unmet clinical needs.5 The same positive trend is expected with the recent entry of the first biosimilar monoclonal antibody infliximab in light of the high uptake levels in Europe. So what do biosimilar medicines deliver?

Biosimilar medicines improve access to indispensable pillars of modern therapies for millions of patients

With more than 10 years of positive patient and treatment experience and some 20 products successfully launched, biosimilar medicines provide a huge opportunity to deliver significantly improved access to modern therapies for millions of European patients in both chronic and acute care in areas such as cancer, diabetes, rheumatoid arthritis or other immune-related diseases. We know that 70% to 80% of all healthcare costs in the EU – an estimated 700 billion EUR – are currently spent on chronic diseases. Biosimilar medicines answer one of Europe’s major healthcare challenges: how to ensure that all European patients get equitable access to treatment?

The European biosimilar medicines industry is the global pioneer of this sector and has over 15 years of experience in developing and manufacturing to the highest quality standards. All biosimilar medicines available in Europe are developed, manufactured and approved according to stringent EU laws designed to set the highest global standards of safety, efficacy and quality. Biosimilar medicines are subject to the same rigorous pharmacovigilance requirements as all other biologic medicines in the EU. The Biosimilar Medicines Group of Medicines for Europe also engages in multilateral dialogues to promote the same high standards for the global development of biosimilar medicines in venues such as the WHO, or the EU-US TTIP regulatory cooperation negotiations.

4 EU-5 countries: France, Germany, Italy, Spain and UK
5 IMS Health (2015). The impact of biosimilar competition


Biosimilar medicines bring better value for healthcare spending

Biosimilar medicines not only deliver more access to medicines, they also improve health outcomes through appropriate earlier use of biologic medicines, while enhancing competition in the biopharmaceutical market. Biosimilar medicines also provide better value for money for healthcare budgets. The impact of biosimilar medicines on healthcare budget savings is real.


The biosimilar medicines industry delivers sustainability for healthcare systems

Thanks to the considerable improvements in patient access to medicines and healthcare, the number of those aged 60+ is increasing twice as fast as before 2007. This growing ageing population, combined with rising treatment costs linked to the growth of chronic diseases and the introduction of complex therapies, is placing stress on the sustainability of healthcare systems. In this context, there is a need for viable innovation to offer better access to therapy and better health outcomes, and this is precisely what the European biosimilar medicines industry is delivering.


The biosimilar medicines industry is a key partner for stakeholders

The Biosimilar Medicines Group engages actively with the European healthcare community, policy-makers, medical and professional societies, as well as with patient associations, to provide the necessary information, understanding and education on complex scientific concepts around biologic and biosimilar medicines. Our group also has extensive experience in engaging with national healthcare communities to build education and understanding about biosimilar medicines.

Through Medicines for Europe and its sector group the Biosimilar Medicines Group, pharmaceutical companies engage in partnership and multi-stakeholder approaches, aimed at fostering mutual understanding and consensus policy making, taking account of all partners’ concerns and constraints, but also expertise and assets.

Medicines for Europe. Better Access. Better Health.