Abstract
BackgroundBeyond evaluation and approval, European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use.ObjectivesThis study aims to (i) review biosimilar information and guidance provided by EMA and national medicines agencies and (ii) explore stakeholder perspectives on the role of regulators in enabling acceptance and use of biosimilars.MethodsThis study consists of (i) a comparative review of regulatory information and position statements across medicine agencies (n = 32) and (ii) qualitative interviews with stakeholders in Europe (n = 14).ResultsThe comparative analysis showed that regulatory information and guidance about biosimilars offered by national medicines agencies in Europe varies, and is limited or absent in multiple instances. Approximately 40% (13/31) of the national medicines agencies' websites did not offer any information regarding biosimilars, and for about half (15/31) no educational materials were provided. Only less than half of national medicines agencies provided guidance on biosimilar interchangeability and switching (8/31 and 12/31, respectively). Among the national medicines agencies that did offer guidance, the extent (e.g., elaborate position vs. brief statement) and content (e.g., full endorsement vs. more cautious) of the guidance differed substantially. Countries that have a strong involvement in EU level biosimilar regulatory activities generally had more elaborate information nationally. Interviewees underwrote the need for (national) regulators to intensify biosimilar stakeholder guidance, especially in terms of providing clear positions regarding biosimilar interchangeability and switching, which in turn can be disseminated by the relevant professional societies more locally.ConclusionThis study revealed that, despite strong EU-level regulatory biosimilar guidance, guidance about biosimilars, and their use differs considerably across Member States. This heterogeneity, together with the absence of a clear EU-wide position on interchangeability, may instill uncertainty among stakeholders about the appropriate use of biosimilars in practice. Regulators should strive for a clear and common EU scientific position on biosimilar interchangeability to bridge this gap and unambiguously inform policy makers, healthcare professionals, and patients. Furthermore, there is a clear opportunity to expand information at the national level, and leverage EU-developed information materials more actively in this regard.
Highlights
With the expiration of patents and other exclusivity rights on many best-selling and high-cost biologics, biosimilar alternatives have gradually been entering the European market over past years
The type of educational material displayed differed across agencies. Either these were designed by the national competent authority (NCA) itself or originated from the European Medicines Agency (EMA)/European Commission (EC) prepared stakeholder information material
This study aimed to assess how regulators, both on a central and national level in Europe, provide information and guidance about the evaluation and use of biosimilars, with a specific focus on guidance related to interchangeability, switching and substitution, and how this is perceived by external demand-side stakeholders
Summary
With the expiration of patents and other exclusivity rights on many best-selling and high-cost biologics, biosimilar alternatives have gradually been entering the European market over past years. Biosimilar approval is based on the demonstration of biosimilarity, i.e., a high level of similarity to the reference product in terms of quality, safety, and efficacy to the reference product. To this end, comprehensive comparability studies with the reference product are carried out [1, 2]. 10 biosimilar marketing authorization applications are under review by EMA’s Committee for Medicinal Products for Human Use (CHMP) and ∼120 originator biologicals products are expected to lose exclusivity in the 10 years, opening up more opportunities for biosimilar development and competition [8]. European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use
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