Background: Beyond 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.
Objectives: This 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.
Methods: This 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).
Results: The 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.
Conclusion: This 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.

**Background:** Beyond 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.
**Objectives:** This 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.
**Methods:** This 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).
**Results:** The 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.
**Conclusion:** This 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.

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

DIA Europe 2022

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