Gonzalez-Sales M, et al. - This paper contemplated if the current bioequivalence limit was adequate to ensure safety and efficacy of rivaroxaban in patients undergoing total hip arthroplasty and total knee arthroplasty, on the basis of its model informed benefit/risk profile. No statistical variation would be detected in the relative risk of major bleeding [MB] of a hypothetical test product (with 20% change in area under the concentration–time curve [AUC]) from the brand name drug. Twenty percent AUC variations did not alter the relative risk of MB. It possibly failed to compromise the efficacy of therapy. A generic drug of rivaroxaban passing the typical bioequivalence assessment could exert a similar safety and efficacy as the brand name drug.