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 from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.
Highlights
Biologics are important for clinical practice because they offer targeted treatments within complex disease areas, such as rheumatology and dermatology, and are considered key for the present and generation of medicines [1, 2]
The difference in clinical practice between generics and biosimilars is ascribed to the perceived risks related to biologics being larger, more complex molecules that are usually impossible to produce in exact copies [5, 20]
The results show that our interviewees view interchangeability as more than a scientific question of likeness between biosimilar and reference products: it pertains to regulatory practices and trust
Summary
Biologics are important for clinical practice because they offer targeted treatments within complex disease areas, such as rheumatology and dermatology, and are considered key for the present and generation of medicines [1, 2]. Biosimilars are follow-on products whose quality, safety and efficacy are highly similar compared and without clinical meaningful differences to that of the biological reference product. In clinical settings in the EU, the decision to exchange (termed interchange) a reference product for a biosimilar can be taken by either a physician (termed switching) or a pharmacist (termed substitution) [15]. While switching of biologics is relatively common in the EU, substitution is not common practice [17]. This stands in contrast to small molecule-generics, which via substitution have led to considerable cost reduction in European healthcare systems [18, 19]. The effects of multiple switching between biologic products remain largely uninvestigated [21, 22]
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