Isabell Remus, chair of the Biosimilar Medicines Group at Medicines for Europe outlines the issues that need to be addressed to keep driving biosimilar uptake in Europe.
Since the first treatment was approved in 2006, Europe has been at the vanguard of the biosimilar medicines sector, approving more treatments over the last 10 years than anywhere else in the world. However, it is only in the last few years that usage has significantly increased, and biosimilars have begun to challenge the established order of care, bringing meaningful access to medicines for patients.
In 2017, the European Medicines Agency’s (EMA) Executive Director, Guido Rasi, stated that “Biosimilars are an integral part of the effective biological therapies available in the European Union (EU)”[1], while the United Kingdom (UK) Healthcare system also issued new guidance on switching to best value biological medicines, acknowledging the positive impact of competition for the NHS.
In late 2018, the EU patent for Humira (adalimumab), the world’s best-selling prescription drug expired, sparking a raft of biosimilar medicines launches. With EU patents for several other blockbuster biologics expiring or nearing expiry over the next 12 months, the opportunity for biosimilars to reach their potential has never been greater. The case for biosimilar use is compelling for healthcare systems, providing patients with better access to treatments while reducing the financial burden on healthcare systems compared to equivalent reference medicines.
Despite the optimism and market potential, there is still room to increase the use of biosimilar medicines in Europe. This is primarily due to variations in therapeutic interchangeability regulations, price and tendering negotiations, and the awareness building of physician and patient communities. These issues, if left unaddressed, pose a serious threat to continued uptake of biosimilars across Europe.
Establishing a sustainable framework for biosimilars
In order to ensure that patients and healthcare systems are able to experience the benefits that biosimilar medicines provide, it is important to take action now to create a sustainable framework for biosimilar adoption. And while we understand that there is no ‘silver bullet’ for biosimilar acceptance, there are specific actions that can drive both acceptance and uptake.
Creating unified regulatory processes and standards that recognize and demonstrate the value of biosimilars
The EU’s regulation of biosimilars has shaped development globally, by establishing the core principles that underpin biosimilar development in other highly regulated markets. However, the EMA does not regulate therapeutic interchangeability, switching, or substitution of a reference product by a biosimilar medicine[2], leaving it up to individual member states, health authorities, and payers to determine. We have seen greater uptake in biosimilar use in countries where clinical or prescription guidelines have been updated to reflect new access opportunities for patients, where the access framework was previously lengthy or complicated. For example, when UK guidelines for granulocyte colony-stimulating factors (G-CSFs) were updated to reflect the cost-effectiveness of biosimilar G-CSF, G-CSF was recommended as a first-line cancer treatment, leading to a 104% increase in uptake of both the reference product and biosimilar filgrastim. Appropriate education, high-quality data, and a deep understanding of local concerns, practices and regulations were key to ensuring that these important medicines are safely integrated into health systems.5
Establishing a consensus of biosimilar confidence across the physician network and patients
A key component to acceptance of biosimilar medicines is the confidence of physicians. As a trusted advisor and prescriber, physicians— as well as pharmacists and nurses— act as an information point for patients. However, effective clinical education around the safety and efficacy of biosimilars among these groups remains low. Additionally, patients themselves regularly have concerns about being switched onto biosimilar medicines from their existing biologics, presenting an additional hurdle to uptake.
Therefore, addressing these concerns through better education, and creating incentives to increase their uptake – such as holistic benefit sharing programmes – are vital for driving widespread confidence and use among these groups.
Optimizing market access
European countries take different approaches in how they procure medicines and negotiate prices, leading to wide variations in adoption of biosimilars. We must move away from the current “winner-takes-all” approach – which discourages manufacturers from staying or potentially investing in the market in the long term – and instead align on incentives and infrastructures that focus on long-term value, sustainability and healthy competition. For example, countries could agree to open tenders as soon as competition enters the market.
What’s next?
I am very excited to Chair the Biosimilar Medicines Sector group of Medicines for Europe, where the programme to shape biosimilar medicines policies is as extensive as it is challenging. With a new European political landscape recently taking office in the European Commission and Parliament, equity of access to medicines is high on the agenda.
A 2020 highlight will unquestionably be the 18th Biosimilar Medicines Conference[3], taking place March 26-27th in Amsterdam. This conference is a fantastic opportunity to exchange views with the key players in the sector. It’s inspirational when we can come together to discuss new ways of getting important biosimilar medicines to patients and shape policy for the year ahead.
Our reflections will extend beyond 2020, and a key question for us is how we deliver access for rare disease patient populations. The healthcare system’s shift to personalised medicine and targeted therapies is exciting, but also means smaller patient populations and potentially greater opportunity cost for manufacturers. We need to work together to help globalize and align policy and regulatory guidelines to ensure that manufacturers continue developing biosimilars in this changing landscape.
Competition will continue to be the biggest hurdle and the biggest opportunity for biosimilars and their uptake. To create effective competition in the next wave of products, manufacturers will need to recognise and respond to the rapidly changing environment, taking into account new scientific advances and needs without compromising the robust framework we have. Working together, across industry, regulators, governments and healthcare systems, we can assess the barriers and ensure the right pathway and robust competition in the market moving forward.
The successful incorporation of biosimilars into treatment programs can expand access and lower costs of effective treatments and improve patient outcomes. Overcoming the current challenges will not be easy but the potential rewards for healthcare systems and patients mean that we are committed to making the change happen.
[1] https://www.ema.europa.eu/en/news/new-guide-biosimilar-medicines-healthcare-professionals
[2] http://www.gabionline.net/Reports/Developing-biosimilars Accessed 25 Oct 19.
[2] https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf
[5] Cornes, Paul and Andriy Krendyukov. “The evolution of value with filgrastim in oncology.” Future Oncology, Vol. 15, No. 13. https://www.futuremedicine.com/doi/full/10.2217/fon-2018-0762#B66
[6] “World Biosimilars Market will surge at 27%+ CAGR up to 2025.” PharmaPhorum. July 2019. https://pharmaphorum.com/partner-content/world-biosimilars-market-will-surge-at-27-cagr-up-to-2025/
