Autori
Mengato D., Messori A.

Topic
Farmacia clinica

Rivista
Clin Exp Rheumatol

Impact factor
3,319

Abstract
An original approach to strengthen the clinical evidence supporting biosimilars has recently been described. According to this method, a network meta-analysis is carried out, that includes not only the equivalence study comparing the biosimilar with the originator, but also the randomized studies comparing the originator with the previous standard of care (SOC). We retrospectively applied this approach to the approval of adalimumab biosimilar (ABP501) for the treatment of active rheumatoid arthritis (RA) in combination with methotrexate in patients not responsive to methotrexate monotherapy. In particular, we compared adalimumab biosimilar ABP501 with Humira (originator). Extending the number of evaluated patients from that enrolled in the equivalence trial to that included in the network meta-analysis, introduced no change in the OR for equivalence and, more importantly, did not affect its between-patient variability. The confirmation of these results based on network meta-analysis proves that the equivalence data between biosimilar and originator are robust.

Link PubMed del paper
https://pubmed.ncbi.nlm.nih.gov/29600941/