Mandatory and non-mandatory switching for biosimilars

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Glintborg and co-authors responded to the comments made by Marc Scherlinger and Thierry Schaeverbeke on their paper ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

Optional Mandatory V19C01

In April 2016, Denmark implemented a national guideline mandating non-medical switching of all patients treated with the originator etanercept Enbrel to biosimilar etanercept, Benepali (SB4).

In their original article, Glintborg et al. reported the results of the mandatory biosimilar etanercept switching in Denmark [2]. However, in their comments on this article, Marc Scherlinger and Thierry Schaeverbeke say that ‘there is evidence suggesting that forcing the switch on a patient is likely to increase the risk of the nocebo effect’ and that the study demonstrates ‘that a mandatory switch is probably not the most efficient strategy for the wide diffusion of biosimilar in chronic rheumatic diseases and reinforcing the evidence of the necessity of a shared physician–patient decision as recommended by many’ [3].

Glintborg et al. point out that of the 2,061 patients who were receiving originator etanercept and thus were eligible for the switch, as many as four out of five (79%) switched to the biosimilar, despite the continued availability of the originator drug (as 25 mg pen or 50 mg powder solution) [4].

The authors also add that ‘the 6-month retention rate after switch (88%) was very similar to results of a recent Dutch study (90%), which reported outcomes of a non-mandatory switch following a specifically designed communication strategy’. Furthermore, the authors found that the disease activity and flare rates three months prior compared to three months after the switch were similar at the level of the individual patients.

For the Danish mandatory switch, no extra resources were allocated to conduct the switch procedure and no specific education of the healthcare personnel was provided. This is in contrast to previous studies that explored non-mandatory switching, where the shared patient–physician decision-making included training of personnel and use of specific questionnaires or communication techniques.

Glintborg et al. admit that it was beyond the scope of their study to explore the practical aspects of the switch procedure including communication strategy with the patients. However, they point to a previous study that ‘demonstrated that a mandatory switch from originator to biosimilar infliximab did not lead to a detectable increase in the use of healthcare resources’.

To determine whether shared patient–physician decision is superior to a mandatory switch in terms of a lower ‘nocebo’ effect, increased treatment efficacy and reduced healthcare costs, Glintborg et al. say that large-scale studies are both ‘necessary’ and ‘highly needed’.

They conclude that their paper ‘adds important evidence to the use of biosimilars in routine care—however, some pieces are still missing in the puzzle’.

Conflict of interest
The authors of the research paper [1] reported conflict of interest, including having received honoraria from various pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].

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1. Glintborg B, et al. Response to ''To switch or not to switch': the missing piece in the puzzle of biosimilar literature?' by Scherlinger et al. Ann Rheum Dis. 2019 Jan 23. pii: annrheumdis-2018-214952. doi: 10.1136/annrheumdis-2018-214952. [Epub ahead of print]
2. Glintborg B, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Annals of the Rheumatic Diseases 2019;78:192-200.
3. Scherlinger M, Schaeverbeke T. ‘To switch or not to switch’: the missing piece in the puzzle of biosimilar literature? Ann Rheum Dis 2019; Jan 4. pii: annrheumdis-2018-214908. doi: 10.1136/annrheumdis-2018-214908. [Epub ahead of print]
4. GaBI Online - Generics and Biosimilars Initiative. Danish etanercept switching study investigates withdrawal rates []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from:

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