2020 Year in Review - Biosimilars
Efficacy and Safety Equivalence of MYL-1402O and Reference in First-Line Treatment of Patients with Stage IV Nonsquamous NSCLC
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).
Clinical Similarity of Bevacizumab Biosimilar MB02 to Reference Bevacizumab in Patients with Nonsquamous NSCLC
Demonstration of Efficacy and Safety Equivalence Between Bevacizumab Biosimilar FKB238 and Bevacizumab Reference in Nonsquamous NSCLC
Efficacy and Safety of ABP 798 versus Rituximab: Comparative Clinical Study in Patients with Non-Hodgkin Lymphoma
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.
Efficacy and Safety Results of Sandoz Rituximab Biosimilar for the Treatment of Diffuse Large B-Cell Lymphoma
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.
Biosimilar Pegfilgrastim-cbqv Demonstrates Similar Clinical Efficacy to the Pegfilgrastim Reference in a Real-World Setting
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.
Phase 3 Study Comparing SB3 and Reference Trastuzumab in HER2-Positive, Early or Locally Advanced Breast Cancer in the Neoadjuvant Setting: 4-Year Follow-Up
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.
Cost-Savings from Conversion to Biosimilar Pegfilgrastim-cbqv Providing Expanded Access to Prophylaxis and Antineoplastic Therapy in NHL
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).
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Results 11 - 20 of 30
Results 11 - 20 of 30