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). Read More ›

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). Read More ›

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). Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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). Read More ›

Real-world utilization data indicate that treatment outcomes with infliximab biosimilars were similar to those with reference infliximab in patients with rheumatoid arthritis. Read More ›