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2020 Year in Review - Biosimilars

Real-world data from the prospective, observational COMPANION-B study showed that the biosimilar SB4 had similar efficacy over 12 months compared with etanercept reference in patients with well-controlled rheumatoid arthritis with stable disease. 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 ›

The findings of a retrospective study indicate that successive switching from reference to 2 different biosimilars was not associated with clinically significant changes in disease activity and function in patients with inflammatory rheumatic diseases. 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 ›

Preliminary real-world retrospective data indicate comparable safety profiles for infliximab-dyyb and infliximab in pediatric rheumatic conditions. Read More ›

Simulation-modeling data demonstrate significant cost-savings by converting from reference pegfilgrastim with on-body injector to biosimilar pegfilgrastim-jmdb for prophylaxis of chemotherapy-induced neutropenia/febrile neutropenia in patients with diffuse large B-cell lymphoma (DLBCL). Read More ›

Exploratory analyses of a phase 3 trial comparing infliximab-qbtx to reference infliximab in patients with rheumatoid arthritis (RA) indicate that multibiomarker disease activity score may be used as an assessment of biosimilarity instead of conventional disease activity measures. 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 ›

Interim results from the phase 3 TROIKA trial demonstrate clinical equivalence between the biosimilar HD201 and trastuzumab reference in terms of efficacy, safety, pharmacokinetics, and immunogenicity in patients with HER2-positive early breast cancer. 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 ›

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