Biosimilars to provide better access at sustainable costs


In the era of the personalisation of therapies, a better access to cure closely relates to the ability to sustain the very high costs of medicines that are far more sophisticaded than just some twenty years ago. The third millenium is characterised by the exploitation of biological medicines, which allows to better tailor the therapeutical intervention on the specific pathological subtype that affect each single patient (and for the determination of which dedicated biomarkers and in vitro tests are required). The other side of the game most of the Western governments have to face is represented by the financial restraints typical of the majority of Western healthcare systems.

Oncology is the new frontier for biosimilars

This is especially true in oncology, as anticancer drugs will account for € 140 billion costs by 2020, according to the position paper on  biosimilars published by the European Society of Medical Oncology (ESMO) in 2016. There were 23 biosimilar products approved in 2016 in the European Union.

The experience and knowledge gained in more than 10 years of biosimilars use is summarised in theBiosimilars in the EU. Information guide for healthcare professionals” published this year by the European Commission and the European Medicines Agency.

A short summary on the industrial perspective to biosimilars, reporting a plenty of useful links, has also been given in a presentation by Adrian van den Hoven, director general of Medicines for Europe, the Federation of national associations of generics producers. “Biosimilar medicines are a real game changer for better health. They can transform oncology care, by prioritising greater and equal patient access to biologic medicines treatment, supportive care and other needed health services”, commented van den Hoven during the works of the ESMO 2017 Congress.

Biosimilars represent an important opportunity to help reducing health expenditure. A special session of the Congress, that took place in Madrid at the beginning of September, discussed how to act in order to build a better confidence towards the prescription of biosimilars, exploring the issue from all the different perspectives of physicians, specialist nurses, patient and the regulatory authority.

In Ireland, the Department of Health of the local government lauched in August a public consultation on the new “National biosimilar medicines policy, aimed to promote the rational use of this category of drugs and to create a sustainable environment in the country.

According to the document, the cost of the community schemes and the High Tech Arrangement has been relatively stable at about €1.7 billion since 2012. But “this apparent headline stability masks a change within the total”, warns the Consultation paper, as the reduction in the amount of the GMS scheme (€1.2 billion in 2013 vs. €875 million in 2016) was paralleled by the increase of the High Tech funds (€442 million in 2013 vs €597 million in 2016)

The importance of HTA

The current European reference framework for biosimilars has been deeply analysed in the survey 2017 Market Review. European Biosimilar Medicines Markets – Policy Overview” conducted by Medicines in Europe among its national associates and relevant companies of the sector.

The document investigates, with respect to each single country, the availability of biosimilars, the pricing system, tendering, reimbursement system, physician and pharmacist policies, patient policies.