Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.

ABSTRACT: Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four f

SUBMITTER: Druedahl LC 

PROVIDER: S-EPMC8751983 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature