"Total evidence" network meta-analysis as a tool for improving the assessment of biosimilars: application to etanercept in rheumatoid arthritis .

Since biosimilars generally have undergone less clinical research than originators, their place in therapy can be strengthened by increasing the amount of clinical evidence supporting their approval. This report describes an approach in which a "total evidence" network meta-analysis is performed that compares the biosimilar not only with the originator but also with the previous standard of care. This analysis was retrospectively applied to etanercept biosimilar in rheumatoid arthritis (end-point = ACR50). Using an increased number of evaluated patients (1,003 for network meta-analysis vs. 596 for equivalence trial), our results confirmed the equivalence index previously estimated from the approval trial of biosimilar.
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