Euronews has gathered a panel of experts, industry leaders and key players in Brussels to address the issue of biosimilar medicines.
With the cost of healthcare in Europe spiralling, experts are considering how we can build the sustainable healthcare system of the future.
One area of keen debate is around biosimilar medicines, which have been shown to help save healthcare systems billions of euros.
These drugs are similar to biologic medicines, which use living organisms as ingredients.
But while biologics are expensive, accounting for around one third of healthcare spending, biosimilars are vastly cheaper to produce.
This is because they are often developed based on a successful biologic drug once its patent has expired.
Marking Global Biosimilars Week, Euronews gathered a panel of experts to discuss how Europe can capitalise on - and shape the future of - biosimilar medicines.
The panel consisted of:
Adrian van den Hoven, Director General, Medicines for Europe
Tomislav Sokol, MEP, Group of the European People's Party & Member of the EU's Special Committee on the COVID-19 Pandemic: lessons learned and recommendations for the future and EU40 Board Member.
Ian Henshaw, Global Head of Biosimilars, Biogen
Luisa Avedano, Chief Executive Officer, European Federation of Crohn’s & Ulcerative Colitis Associations
With healthcare costs spiralling, and resources stretched even further throughout Europe following the COVID-19 pandemic, member states are looking for ways to reduce costs while maintaining or improving patient outcomes.
So our panel was asked why biosimilars are not currently uniformly used throughout the European Union.
Patchy use of biosimilars across Europe
Adrian van den Hoven, the director general of Medicines for Europe, insisted they have made a “huge difference” across the bloc.
“They’ve increased access by 50 per cent over the period when there were no biosimilars,” he said.
“Unfortunately, that doesn't mean all the patients that should be treated are receiving that treatment. There have to be policies to enable greater use of biosimilar medicines. These are very low cost medicines but there are different barriers out there.”
For example he stated there were around 25,000 people in Italy with rheumatoid arthritis who could be treated with them but are not, while in the United Kingdom, 25,000 of these patients can now be treated with biosimilars thanks to changes in their rules.
For Luisa Avedano, the chief executive officer of the European Federation of Crohn’s & Ulcerative Colitis Associations, only 20 to 25 per cent of the patients in her associations have access to biosimilars.
“We are dealing with a community which is fully aware of the importance of biosimilars, but we are not yet experiencing the big changes that were supposed to happen,” she said.
The problem on the political side is an issue of the competencies between member states and the EU, pointed out Tomislav Sokol, MEP in the Group of the European People's Party.
“The EU cannot unify what member states fund in terms of healthcare,” he said, with the financing, organisation, and management of healthcare systems resting with member states.
They can however influence it, by making the European Medicines Agency (EMA) procedures “simpler, faster, and remove some of the unnecessary parts of the process”.
Ian Henshaw, the global head of Biosimilars at Biogen, was positive about the start of the biosimilar strategy in Europe, saying he commended what the bloc has done so far.
“Yes you’ve got a split of results, but you've also got great case studies of where it’s working. So $18 billion dollars has been saved since its inception,” he said.
Creating ‘critical mass’ for biosimilars
Luisa Avedano then pointed out it was important to create “the kind of critical mass that, based on the evidence, can show it’s possible to make changes”.
She said we could do this by ensuring policy makers, industry, medical societies, and associations all join forces. She added that one issue was that the safety and efficacy of the medicines was not given enough prominence - “in terms of raising awareness it’s important to stress the point that we are talking about something that’s fully transparent, safe and can give more patients the opportunity to be treated.”
Adrian van den Hoven agreed that while there is a “wealth of data available from the EMA”, it is not disseminated widely enough, so he called for an improvement in communication regarding the benefits of biosimilars.
Biosimilars have saved a minimum of €18 billion
Despite their uneven distribution across Europe, biosimilars have had a “massive impact” already according to van den Hoven.
“On savings, its true biosimilars have had a massive impact. At a minimum they've saved €18 billion, that’s fantastic for healthcare systems that are struggling financially.”
“However we're not in the business of saving money, but saving lives,” he added. “A small share of the savings, say for inflammatory bowel disease, or rheumatoid arthritis, or oncology could be reinvested, because often these conditions need not just the medicines but other services which are sometimes paid out of pocket by patients.”
Tomislav Sokol allocation of resources is critical - and it is a sticky issue politically. “When you decide to fund medicine A, you are deciding not to fund medicine B,” he said. “A lot of these discussions are politicised, very populist in many cases, and are not based on rationale.”
In his own country of Croatia, where resources are tighter in relation to wealthier member states, these allocation decisions are particularly hard, he added.
But he said politicians at the EU have an opportunity to “make big changes, and create a European health policy” in the wake of improved cooperation on health following the COVID-19 pandemic.
Ian Henshaw said companies like his are offering a lower price on these medicines than biologics, through free and fair competition, and that creating an open environment, the area will flourish.
“There’s a huge untapped potential” in the biosimilars market, Adrian van den Hoven said.
“Over the next 5 years biosimilars could target 100 new medicines, this would bring price competition and therefore improved access to over 100 medicines in Europe,” he said. “If successful this will mean biosimilars will be equivalent to generic medicines in terms of the sustainability of the access and savings they can bring to the healthcare system.”
But he pointed out regulations need to be updated to enable biosimilars to be developed for rare diseases - something that “takes years” according to Sokol.
It is “very hard” to change European legislation, he said, with the Commission being responsible for proposing changes, then the European Parliament and the member states needing to get on board, then the implementation taking more time. “That’s the nature of the EU decision making process,” he said.
How can Europe shape the future of biosimilars?
Asked to summarise how Europe can press forward with its biosimilar strategy, Ian Henshaw suggested “ultimately, it’s about patients.”
As long as we can agree that saving or transforming more lives is the overall output, and we use the wealth of data and experience available, he said, “I have a lot of hope for what we’re about to do.”
Adrian van den Hoven called it an “incredible opportunity”, where there is the chance to “satisfy finance ministers” while more importantly treating more patients with “the same amount or at times less money”.
Luisa Avedano called for “less inequality in access to drugs” and equal treatment for patients across the EU. “There are still lots of differences between countries, but I hope with biosimilars this big issue will be finally solved,” she said.
And Tomislav Sokol reiterated that if the EMA procedures could be simplified and made faster, “biosimilars are the way of the future”.
About our panel
- Tomislav Sokol, MEP, Group of the European People's Party & Member of the EU's Special Committee on the COVID-19 Pandemic: lessons learned and recommendations for the future and EU40 Board Member.
Tomislav Sokol was a Member of the Croatian Parliament until July 2019, when he became a Member of the European Parliament. He is a Member of the Committee on the Internal Market and Consumer Protection (IMCO), Special Committee on the COVID-19 pandemic: lessons learned and recommendations for the future (COVI) and also EPP Vice Coordinator in COVI Committee, and a Substitute Member of the Committee on the Environment, Public Health and Food Safety (ENVI) and Committee on Regional Development (REGI) in the European Parliament.
- Adrian van den Hoven, Director General, Medicines for Europe
Adrian van den Hoven joined Medicines for Europe as a Director General in September 2013. His priorities at Medicines for Europe are to stimulate competition in off-patent medicine markets, foster access to medicine, support policy measures for sustainable pricing, promote efficient regulatory standards and develop a coherent EU industrial strategy to support the long-term viability of the generic, biosimilar and value added medicines industries.
- Ian Henshaw, Global Head of Biosimilars, Biogen
Ian Henshaw is the Global Head of Biogen’s Biosimilars Unit and has more than 20 years of experience in the pharmaceutical industry. Ian was also a Non-Executive Director of Samsung Bioepis. Prior to joining Biogen. Ian was at The Medicines Company for more than six years where his last role was Vice President and Head of Strategy and Business Development (EMEA).
- Luisa Avedano, Chief Executive Officer, European Federation of Crohn’s & Ulcerative Colitis Associations
Luisa Avedano is the Chief Executive Officer of the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) since 2009. She is in charge of the strategic, policy and daily management of the EFCCA’s Secretariat as well as of the assistance and support of the Chairman and the Executive Board members in fulfilling their responsibilities and tasks.