Authors: Mengato D, Chiumente M, Messori A

Journal: International journal of clinical pharmacology and therapeutics 57 (3), 160-162

Abstract: The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have recently approved four different trastuzumab biosimilars, marketed by different pharmaceutical companies. Biosimilars, unlike their originators, are typically supported by less clinical data about safety and efficacy. The objective of our analysis was to demonstrate that one of the approved trastuzumab biosimilars (MYL-1401O) is as effective as its originator in terms of hazard ratio (HR) of progression-free survival (PFS). METHODS: We carried out a network meta-analysis to compare the HR values for biosimilar, originator, and standard of care (SOC). Our analysis included a preliminary pairwise meta-analysis. The pooled HR for all pairwise comparisons was the output of the analysis (fixed-effect inverse variance method), along with 95% confidence intervals (CIs). The indirect comparison between biosimilar and SOC was performed using a network meta-analysis software. RESULTS: We estimated an HR of 0.59 (95% CI: 0.52 – 0.66) for the comparison between PFS values of originator and SOC, 0.97 (95% CI: 0.74 – 1.28) for biosimilar vs. originator, and 0.61 (95% CI: 0.44 – 0.83) for biosimilar vs. SOC. Our network meta-analysis increased the overall number of evaluated patients from 458 to 1,955.

CONCLUSION: According to the network meta-analysis, MYL-1401O biosimilar is as effective as its originator in terms of HR of PFS.