OBJECTIVES : A lack of knowledge among stakeholders about biosimilars and their regulatory framework may act as barrier for the use of biosimilars. This study aims to (i) map regulatory guidance and information dissemination for biosimilars by the European Medicines Agency (EMA) and the National Competent Authorities (NCAs) in Europe and (ii) investigate the perspectives of healthcare professionals (HCPs) and industry about regulatory information for biosimilars.

METHODS : The study consisted of a (i) review of the literature, (ii) screening of the EMA and NCA websites and (iii) semi-structured interviews with HCPs and industry across Europe. Interviews were audio-recorded and transcribed ad verbatim. Transcripts were analysed using the thematic framework approach.

RESULTS : Almost half (13/31) of the reviewed NCA websites in Europe contained no information about biosimilars. Fifteen NCA websites displayed educational materials about biosimilars, of which almost half relied partially or completely upon EMA’s educational material. In total, 14 semi-structured interviews were conducted (seven interviews for each stakeholder group). HCPs and industry identified that both EMA and NCAs play a crucial role in informing and guiding stakeholders about (the development/evaluation/use of) biosimilars. EMA was considered a primary information source by most interviewees, acknowledging the comprehensive and trustworthy nature of the information and guidance provided. Opinions about the transparency and insight provided in the evaluation of biosimilars by the European Public Assessment Report varied. On a national level, a need for more guidance by NCAs, specifically regarding interchangeability, (multiple) switching and substitution, was identified. This gap was considered to be partially compensated by information from HCP associations.

CONCLUSIONS : Whereas stakeholders recognize the role of EMA in guiding and informing them about biosimilars, room for improvement about the guidance by NCAs about the use of biosimilars in clinical practice was identified. In addition to the role of regulatory bodies, peer-to-peer information can help consolidating confidence about biosimilars.