The report, which surveyed more than 90 endocrinologists and more than 90 nephrologists from the US and Europe, found that endocrinologists require extensive efficacy data from multiple phase III trials, involving in excess of 1,000 patients to feel comfortable about prescribing biosimilar insulin analogues.

In fact, endocrinologists’ expectations for clinical trials of biosimilar insulin analogues exceed those of the European Medicines Agency (EMA); the EMA’s draft guidelines for biosimilar insulin analogues state that there is no anticipated need for specific efficacy trials.

The report also found that, when choosing between different biosimilars, endocrinologists would place non-significant differences in the safety and efficacy, as well as the robustness and number of clinical trials at the top of their list in influencing their decision on which biosimilar to use.

The report concludes that ‘conducting a lean clinical development programme for insulins may be sufficient for EMA approval, but endocrinologists are unlikely to readily adopt such a biosimilar.’

This sentiment has also been voiced elsewhere, for example, by the German Working Group of Paediatric Endocrinology (APE), which is calling for ‘precaution’ rather than ‘aftercare’ in the case of biosimilars. The APE has criticized EMA’s ‘automatic … approval of biosimilars for all indications’ and is asking for a Europe-wide discussion on their request for ‘greater safety awareness’.

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