Biosimilars are Bioequivalent to Original TNF Inhibitors Save

Chingcuanco and coinvestigators have reported on their comparative analysis of biosimilars and their originator TNF inhibitors in the current issue of Annals of Internal Medicine.  (Citation source: http://buff.ly/2arTd1q)

Their Cochrane based systematic review of 19 studies included 8 phase 1 randomized clinical trials (RCTs), 5 phase 3 RCTs and 6 observational studies. The phase 3 trials were done with rheumatoid arthritis patients, and observational studies involved RA or inflammatory bowel disease.  These RCTs found the biosimilar to be bioequivalent in pharmacokinetic studies and clinical outcomes.

Phase 3 trials suggested similar clinical responses and adverse events. Adverse events were usually of mild to moderate severity. Two cross-sectional observational studies showed cross-reactivity between products, whereas 4 cohort studies of patients switched from reference to biosimilar products suggested similar efficacy and safety outcomes.

This systematic review further establishes the utility and safety to using biosimilars in RA and related indications.