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- Druedahl, Louise C., et al.
(författare)
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Interchangeability of biosimilars : A study of expert views and visions regarding the science and substitution
- 2022
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 17:1
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Tidskriftsartikel (refereegranskat)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.
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2. |
- Kälvemark Sporrong, Sofia, et al.
(författare)
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Methodological and disciplinary competence and insecurity in qualitative research
- 2022
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Ingår i: Contemporary Research Methods in Pharmacy and Health Services. - : Elsevier. - 9780323918886 ; , s. 567-573
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Bokkapitel (refereegranskat)abstract
- This chapter is based on discussions at a workshop at the Nordic Social Pharmacy Conference in 2019, named How do we know it’s good? A workshop on quality criteria in qualitative social and clinical pharmacy research. After an introduction, the chapter continues with a glance at two different epistemologies. Thereafter, reflections on the challenges that many social pharmacy researchers meet as they come from a natural science background into qualitative research are presented. Specific aspects presented and discussed are: methodological and disciplinary competence and insecurity, reflexivity, transparency, checklists, quality criteria, sample size, and saturation.
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