Sustainable biosimilar competition: clinical, regulatory and policy insights

Biological medicines have led to significant improvements in the treatment of diverse complex, life-threatening, and chronic disorders, and represent a growing share of pharmaceutical expenditure worldwide. However, the success and often high prices of these biological therapies has put substantial pressure on healthcare budgets. Following loss of exclusivities of original biological medicines, the arrival of biosimilars – which are highly similar follow-on versions - offers the opportunity to improve the affordability of biological therapies, while safeguarding equally effective and safe treatment for patients. The price competition introduced by biosimilar market entry has shown to lead to lowered treatment costs, relieving healthcare budgets. Furthermore, the savings derived from biosimilar competition may expand patient access to biologic therapies and free up budgetary room for innovative treatment options. However, at present, biosimilar adoption faces several challenges, limiting their competition potential and therefore also the associated benefits for healthcare systems and patients. Consequently, questions have risen on how to unlock the potential of biosimilars and foster a more sustainable off-patent biological medicines market environment. The aim of this PhD project is to address adoption challenges faced by biosimilars in Europe and identify proposals on how to leverage biosimilar competition in a more sustainable manner. This with the ultimate goal of formulating recommendations that support a long-term sustainable and balanced off-patent biological medicines market dynamics. To achieve this, this PhD research draws insights from stakeholders and other sources from a clinical, regulatory and policy perspective. The PhD research is carried out from a multidisciplinary perspective, and includes a combination of quantitative (literature reviews, document analysis, and surveys) as well as qualitative studies (semi-structured interviews, focus group discussion). The framework of the research is structured around the main barriers for biosimilar use and aims to elucidate 1) stakeholder knowledge and perceptions of, and insights on biosimilars and their use including educational and incentives needs, 2) regulatory and clinical components that may impact biosimilar adoption, and 3) biosimilar policies, especially those related to procurement, and best practices to leverage biosimilar competition in a more sustainable way. The derived recommendations aim to inform the implementation of biosimilars in clinical practice and support decision makers with policymaking.