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2020 Year in Review - Biosimilars

Confirmatory phase 3 clinical trial results demonstrated equivalence between MYL-1402O and bevacizumab in terms of efficacy, safety, and immunogenicity in the first-line treatment of patients with stage IV metastatic, nonsquamous non–small-cell lung cancer (NSCLC).
The results of a phase 3 trial demonstrated the clinical equivalence of MB02 with bevacizumab reference product in terms of efficacy, safety, and immunogenicity in patients with stage IIIB/IV nonsquamous non–small-cell lung cancer (NSCLC).
Phase 3 trial results demonstrate equivalence between the bevacizumab biosimilar FKB238 and bevacizumab reference in terms of efficacy and safety in patients with advanced/recurrent nonsquamous non–small-cell lung cancer (NSCLC).
Final analysis data from a confirmatory, randomized phase 3 study demonstrated clinical similarity between rituximab reference and its biosimilar ABP 798 in patients with CD20-positive non-Hodgkin lymphoma in terms of efficacy, safety, and immunogenicity.
Interim analysis results from the prospective, postapproval REFLECT study indicate the Sandoz rituximab biosimilar treatment was associated with safety and efficacy profiles consistent with those previously described for R-CHOP in untreated patients with diffuse large B-cell lymphoma.
A proof-of-concept study showed the feasibility of conducting comparative-effectiveness research at scale to promote value-based decision-making in oncology; it also confirmed efficacy equivalence between the biosimilar pegfilgrastim-cbqv and pegfilgrastim reference for the prophylaxis of chemotherapy-induced febrile neutropenia.
Pegfilgrastim biosimilars have provided significant cost-savings to the Centers for Medicare & Medicaid Services among the Oncology Care Model population, possibly resulting from stabilization and reduction in net-acquisition-cost prices of reference pegfilgrastim rather than greater utilization of biosimilars.
An ongoing extension study from the phase 3 trial of trastuzumab biosimilar SB3 and trastuzumab reference supports similarity in terms of long-term cardiac safety and survival in patients with HER2-positive, early or locally advanced breast cancer.
Simulation-modeling data indicate significant cost-savings may be generated by converting from reference pegfilgrastim ± on-body injector to biosimilar pegfilgrastim-cbqv for prophylaxis of chemotherapy-induced (febrile) neutropenia in patients with non-Hodgkin lymphoma (NHL).
Real-world utilization data indicate that treatment outcomes with infliximab biosimilars were similar to those with reference infliximab in patients with rheumatoid arthritis.
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