Biosimilar use has led to increased access to biological treatments for some molecules wherein switching from originator to biosimilar has been one means to exchange products [1, 2]. Another but less applied way to exchange the products is via substitution by a pharmacist, i.e. without informing the prescriber [2]. Substitution of biosimilars is a topic with many contrasting views and has been highly debated [3-12]. More clarity on the matter is needed because health care has reached a point where policy decisions need to be made about whether substitution should become a practice in biosimilar use. Therefore, researchers from Denmark, Sweden and The Netherlands investigated the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars [13].
The study used qualitative interviews wherein European Union (EU) national medicines regulators and industry experts expressed high confidence in the science behind exchanging biosimilars for 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. Despite this, only a few participants saw the need for additional scientific data to support substitution. In addition, the participants reported that interchangeability also pertains to regulatory practices and trust, and thus is not only a matter of scientific likeness between biosimilar and reference products [13].
The results showed that biosimilar companies lack interest in substitution and are therefore not expected to drive change in this area [13]. However, other developments in the area include publication of the strategies of the European Commission (EC) and the European Medicines Agency (EMA) [14-15]. These show that the EC is considering the political and financial aspects of substitution of biosimilars, but also that the EMA is not expected to play an increasing role in the science underpinning interchangeability. Nonetheless, these two stakeholder strategies will shed light on how biosimilar substitution will look in the EU, and this is likely to influence other jurisdictions.
Conflict of interest
The authors of the research paper [13] reported conflict of interest, including being funded by a PhD fellowship grant to the University of Copenhagen from Leo Pharma. For full details of the authors’ conflict of interest, see the research paper [13].
Abstracted by Louise C Druedahl, MScPharm, PhD, Copenhagen Centre for Regulatory Science (CORS)/Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Denmark.
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Interchangeability. An insurmountable fifth hurdle?
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