A growing number of biologic medicines have been developed and approved over the past decade, improving the lives of patients worldwide. However, patient access to biologics has been limited, partly due to their relatively high cost. Biosimilars are increasingly available across Europe, bringing with them the opportunity to generate competition for biologic therapies and thereby lower medicine costs and increase patient access. This report puts forth a framework for the evaluation of sustainability in the biosimilars market and identifies its key policy elements. Based on these criteria, current policies and market dynamics are assessed to identify where risks to sustainability exist and the best practices that can support the long-term positive contribution of biosimilars in Europe.
Biosimilars are now an integral part of the market for biologics, which accounted for $277 billion in sales globally in 2017 and is projected to reach $452 billion by 2022. Use of biosimilars in the EU5 countries alone stands to offer savings of more than €10 billion between 2016 and 2020.
To sustain the market for biosimilars in the long-term, ongoing benefits for all stakeholders must be ensured. Sustainable policies therefore provide for patient access and physician prescription choice, provide a means to manage existing healthcare budgets for payers, and safeguard a healthy level of competition, supply, and product safety and quality.
Current European policies and market dynamics were assessed to identify the risks and challenges to sustainability, with the aim to identify best practices that can be leveraged to support long-term sustainability of the biosimilars market in Europe. Overall, biosimilars have increased patient access to biologic medicines, and this growth is supported by a regulatory environment and clinical guidelines that create a neutral or positive climate for biosimilars relative to originator biologics, and thus supports their sustainability.
However, some elements of a sustainable system were found to potentially be at future risk due to payer driven-switch and specific purchasing systems. Specifically, payer-driven switch was found to reduce physician prescription choice, potentially leading to loss of product options currently working for patients and reducing patient involvement in the treatment decision. Additionally, single-winner tenders were found to disrupt market forces and competition, thereby not supporting long-term sustainability. Several alternative policies currently in place in Europe can be leveraged to ensure and support the long-term sustainability of the biosimilars market while additionally fulfilling the needs of all stakeholders.
Sustainability in the biosimilars marketplace ensures benefits for all stakeholders
Launch of a biosimilar brings with it increased patient use of biologic medicines
The European regulatory environment and clinical guidelines are generally positive toward sustainability
Several policies currently in place in Europe can be leveraged to support the long-term sustainability of the biosimilars market