Comparative Efficacy and Safety of Generic vs Brand-Name Meropenem for Anti-infective Use in Real-world

Abstract

There is little information on whether generic meropenem can be as safe and effective as brand-name meropenem. This retrospective study aimed to compare the efficacy and safety of generic vs brand-name meropenem for infection treatment. Patients (aged ≥18 years) prescribed generic or brand-name meropenem between January 1, 2020, and December 31, 2021, were identified from the hospital information system database of Sichuan Provincial People's Hospital and Sichuan Academy of Medical Sciences. The efficacy outcomes included clinical efficacy, changes in laboratory testing indicators related to infection, and bacterial clearance rate. Safety outcomes included incidence of adverse reactions, abnormal liver and kidney function indicators, and abnormal blood system indicators. A total of 2288 patients (1414 [61.8%] males and 874 [38.2%] females, mean [IQR] age 66 [52-77] years) were eligible for analysis, of whom 1234 were prescribed generic meropenem. Both the generic and the brand-name groups included 600 patients (729 [60.8%] female, mean [IQR] age, 63 [51-76] years) after propensity score matching. The generic meropenem was comparable to the brand-name drug about efficacy (447 [74.5%] vs 462 [77.0%]; P = 0.360). The generic meropenem was associated with lower rates of bacterial clearance (83 [13.8%] vs 120 [20.0%]; P = <0.001). The brand-name may have a better elimination effect on Escherichia coli compared with its generic counterpart (6 [20.0%] vs 25 [55.6%]; P = 0.002). The risks of adverse reactions were not significantly different between the two groups (20 [3.3%] vs 25 [4.2%]; P = 0.447). In conclusion, the generic meropenem was as effective and safe as brand-name meropenem in adult hospitalized patients diagnosed with serious bacterial infections.