Switching from a reference medicine to a biosimilar does not affect patient safety, according to a data review by a research team that looked at 90 studies involving 14,225 subjects for signs of increased immunogenicity associated with switching.
The review by researchers from Sandoz, Rocky Mountain Cancer Centers and Oregon Medical Research Center, published in the journal Drugs, found that in three large multiple switch studies involving different biosimilars, no major efficacy or safety differences were evident after switching between reference and biosimilar. While two studies reported reduced efficacy or increased dropout rates, they did not report decreased safety.
As biosimilar approvals are based on lack of clinically meaningful differences from their reference products, the results were “not particularly surprising,” according to the review’s co-author Gillian Woollett, senior vice president at Avalere Health.
However, it was “good to confirm it with a thorough analysis, not least as the conjecture was beginning to assume a problem with biosimilars that is shown to be unwarranted,” Woollett told FDAnews.