Biosimilars

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 ›

Exploratory analyses of a phase 3 trial comparing adalimumab-afzb with reference adalimumab in patients with rheumatoid arthritis (RA) indicate a multibiomarker disease activity score may be a sensitive and objective assessment of biosimilarity that does not require subjective assessments needed for conventional disease activity measures. Read More ›

Data from the ongoing PROPER study indicate switching from reference adalimumab to its biosimilar SB5 was not associated with any clinically meaningful difference in disease score from baseline in patients with rheumatoid arthritis (RA), axial spondyloarthritis, or psoriatic arthritis. Read More ›