Biosimilars - to switch or not to switch

Biosimilars/Research | Posted 25/01/2019 post-comment0 Post your comment

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

Switching V19A17

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).

However, one year later, out of a total of 2,030 patients treated with etanercept identified in the nationwide quality registry, DANBIO, only 1,623 (80%) had been switched to Benepali [2]. This means that 20% of patients were still being treated with Enbrel. 

Scherlinger and Schaeverbeke point out that there are two strategies for switching patients from more expensive originator biologicals to biosimilars, with their 20%‒50% lower costs, either a shared decision or a mandatory switch.

Switching to a biosimilar via a physician–patient shared decision has, according to the authors, been favoured by rheumatology scientific societies, by an international consensus group and by patient associations. In fact, they point out that real-life studies reporting the acceptance of switching from Enbrel to SB4 using shared decision and communication have reported acceptance rates of 92–99%. In addition, Scherlinger and Schaeverbeke say that there is evidence suggesting that forcing the switch on a patient is likely to increase the risk of the nocebo effect, having a negative effect on the patient and on the physician–patient relationship. This nocebo effect could cause a need for a switch back or possibly the need to switch to another originator biological.

The authors conclude that ‘considering this body of evidence’, they ‘believe that Glintborg’s study was the missing piece in the puzzle of the biosimilars literature, demonstrating 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’.

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest. 

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1. 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]
2. GaBI Online - Generics and Biosimilars Initiative. Danish etanercept switching study investigates withdrawal rates []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from:

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