The European Union (EU) is in the process of reviewing its pharmaceutical legislation, and a recent IQVIA white paper titled “Assessing the Biosimilar Void” highlights the potential for fostering more robust biosimilar competition to enhance equitable access to biological medicines. Here are the key takeaways from the report:
1. The Biosimilar Void until 2032: The report underscores a significant gap in the biosimilar market. It reveals that approximately €15 billion worth of biological medicines will lose their exclusivity by 2032, with no visible biosimilar competition in sight. This lack of competition represents nearly 25% of the total biosimilar opportunity.
2. Correcting Access Disparities: The white paper addresses the widening access disparities in the biological medicines market. To rectify this situation, it identifies essential regulatory and market policy reforms aimed at encouraging investment in biosimilar development and improving the utilization of biosimilar medicines.
3. Speeding Up Access: The report emphasizes the need to expedite biosimilar development by enhancing regulatory efficiency at the EU level. This includes streamlining regulatory processes based on scientific knowledge and experience. Additionally, a dynamic approach to eliminating access barriers, such as reimbursement issues during biosimilar market entry, is crucial.
The IQVIA report provides a comprehensive analysis of what is required to support the development and competition of biosimilar medicines up to 2032, involving various European institutions, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and EU member states.
Julie Marechal-Jamil, Director of Biosimilar Policy & Science at Medicines for Europe, commented on the report’s release. She stressed the vital role of biosimilar medicines in improving patient access and healthcare budget savings. As patient demand for biological medicines continues to grow, she urged a multi-stakeholder policy approach to promote more biosimilar development and access. The report identifies several policy shortcomings that need immediate attention to ensure access to medicines in the future.
In summary, the IQVIA white paper highlights the significant opportunity for enhancing biosimilar competition in the EU’s pharmaceutical market. It underlines the need for comprehensive policy reforms and regulatory efficiency to stimulate biosimilar development, ultimately improving equitable access to biological medicines while saving on healthcare costs.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
