First, to substantiate the claim of equivalence between a biosimilar and the reference biopharmaceutical, there is a need for adequately powered equivalence or non-inferiority studies.
In particular, this relates to the availability of adequately powered equivalence or noninferiority studies, the need for comparative data about the effectiveness in a real-world setting rather than the efficacy in a structured setting, and the use of health outcome measures instead of surrogate endpoints.
First, the absence of a non-active treatment arm (double-dummy) in the study design, and the absence of statistical power for equivalence testing between fish oil supplementation and montelukast, is a weakness that should be acknowledged.
We estimated sample sizes to show a difference between wet combing and phenothrin lotion treatment with 95% confidence, 90% power, and equivalence between the two phenothrin groups to within 20%.
Five cases over a range of thermal powers and equivalence ratios were investigated, each of which underwent different amplitude limit-cycle oscillations.
The MATREX trial was a pragmatic, multicentre, randomised controlled trial powered for equivalence.
Although we conclude no significant difference, this study was not powered for equivalence.
In this randomised, controlled trial powered for equivalence, 526 patients hospitalised with acute COPD exacerbation were enrolled from four centres in the UK.
Of note, these trials were not designed or powered as equivalence studies and do not provide definitive data to inform clinicians about how much nutritional support is enough [ 54].
While the study is powered for equivalence, once we have established non-inferiority, we also have the ability to examine whether the enhanced nurse-internet intervention is superior on maternal and child health outcomes.
