BioTrends Research Group, a research and advisory firms for specialized biopharmaceutical issues, finds that surveyed U.S. and European endocrinologists require extensive efficacy data from multiple Phase III trials, involving in excess of 1,000 patients to feel comfortable prescribing biosimilar insulin analogues.
The Biosimilars Advisory Service report entitled Physician Perspectives on Erythropoiesis-stimulating Agents, Insulin, and Human Growth Hormone provides analysis of survey results from over 90 endocrinologists, as well as more than 90 nephrologists. The report finds that 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 finds that if surveyed endocrinologists had to choose between multiple biosimilars of the same reference product, the most influential factors on their prescribing decision would be any non-significant differences in the safety and efficacy, as well as the robustness and number of clinical trials.
"Our research shows that endocrinologists are more demanding than other specialists, such as oncologists and gastroenterologists, in terms of what they need from biosimilars trials in order to feel comfortable using them," said Biosimilars Research Director Kate Keeping. "Conducting a lean clinical development program for insulins may be sufficient for EMA approval, but endocrinologists are unlikely to readily adopt such a biosimilar. In the United States, insulins cannot currently be approved through the biosimilars pathway and therefore require more extensive trials. These findings suggest that a high level of investment in clinical development will be required to maximize uptake of biosimilar insulins." Surveyed nephrologists and endocrinologists also revealed pivotal insights to understanding the current and future uptake of biosimilars, including their level of familiarity, concerns, drivers and constrainers of adoption, views on indication extrapolation, attitudes towards reimbursement, the expected impact of 'biobetters' and the clinical trial requirements for biosimilars.