OBJECTIVES: Biosimilars are increasing in the market worldwide. Health Technology Assessment (HTA) Agencies/Organizations have the potential to play a role on assessment of biosimilars to support decision-makers. However, there is an uncertain about the role of HTA of biosimilars. Our main objective is to map the extension, scope, methodological practices and outcomes of HTA of biosimilars.

METHODS: We used a scoping review method to map the evidence about biosimilars in the context of HTA organizations. The research question is based on PCC: Population (no restrictions), Concept (biosimilar), and Context (HTA organizations). We comprehensively search on HTA/ NHS EED databases. HTA reports were hand-searched in websites of HTA organizations, members of INAHTA, HTAi, EUnetHTA, and RedETSA. We have only included reports classified as full HTA, mini-HTA or rapid-review.

RESULTS: We identified 361 documents with any biosimilar content. Of these, 106 were considered as potential HTA of biosimilars and classified with Merlin et al. criteria. We identified 83 HTA reports of biosimilars and 25 documents were excluded. Fifteen (18%) reports were classified as full HTA, 12 (14%) reports as mini-HTA, and 54 (65%) reports as rapid review. The most commonly studied biosimilar was infliximab. The HTA organizations evaluated the same biosimilars with different methodological approaches. There is a lack of transparency in the processes, mainly in the evidence selection process and the quality assessment of studies and overall evidence. Efficacy and safety were always analyzed, immunogenicity was often considered, and, substitution and interchangeability were rarely considered.

CONCLUSIONS: HTA of biosimilars are emerging in the context of HTA organizations. The scopes and methodological approaches adopted are not standardized, with a lack of essential methodological steps to guarantee the quality, confidence and robustness of HTA reports.