Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging

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.

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking

“…Data from both randomized controlled trials as well as from observational studies did not corroborate any of the voiced safety concerns with switching ( Cohen et al, 2018 ; Barbier et al, 2020c ). 3) Regulators should provide a more explicit and homogenous scientific position regarding biosimilar interchangeability and (multiple) switching ( Barbier and Vulto, 2021 ; Barbier et al, 2022 ). Similarly, clear and up-to-date position statements from learned healthcare professional and patient associations regarding biosimilar use and switching are paramount in building trust among healthcare professionals ( Somers et al, 2020 ).…”

“…3) Regulators should provide a more explicit and homogenous scientific position regarding biosimilar interchangeability and (multiple) switching Barbier et al, 2022). Similarly, clear and up-to-date position statements from learned healthcare professional and patient associations regarding biosimilar use and switching are paramount in building trust among healthcare professionals (Somers et al, 2020).…”

Nurses’ Knowledge and Attitudes towards Biosimilar Medicines as Part of Evidence-Based Nursing Practice—International Pilot Study within the Project Biosimilars Nurses Guide Version 2.0

“…According to the definition by the European Medicines Agency (EMA), a biosimilar is a medicine with a very similar quality, safety and immunogenicity profile to already approved original biological medicines [ 1 , 2 , 3 ].…”

“…Biopharmaceuticals or biological products are medicinal products manufactured using living systems, i.e., genetically modified cells, bacteria, yeast or mammalian cells [ 1 ]. The most important distinguishing feature of biological drugs is the way they are produced; they are produced by living cells and therefore it is not possible to describe a detailed protocol for their production, which significantly distinguishes them from synthetic drugs.…”

“…A biosimilar medicine (BSM) is produced as a very similar copy of a previously registered innovative biological medicine [ 1 ]. A biosimilar drug is not a generic drug in pharmacological terms [ 5 ].…”