2020 Year in Review - Biosimilars
The totality of evidence generated from comparative systematic stepwise assessment of HD201 and trastuzumab reference in terms of analytical, pharmacodynamic, pharmacokinetic, and clinical similarity demonstrated the equivalence of HD201 to trastuzumab.
Population-Based, Real-World Data of Neoadjuvant Chemotherapy + Pertuzumab + SB3 in HER2-Positive, Early Breast Cancer
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.
Safety and Clinical Evaluation of Trastuzumab-dttb + Pertuzumab in Patients with HER2-Positive Breast Cancer
Phase 3 TROIKA Results Demonstrate Clinical Similarity Between HD201 and Trastuzumab Reference in HER2-Positive Early Breast Cancer
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.
Multibiomarker Disease Activity Scores as a Biosimilarity Assessment to Compare Biosimilar Infliximab-qbtx with Infliximab-EU in Patients with Active RA
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.
Comparative Safety Analysis of Infliximab with Its Biosimilar Infliximab-dyyb in Pediatric Rheumatic Conditions
Impact of Successive Switches of 2 Different Etanercept Biosimilars on Outcomes in Inflammatory Rheumatic Diseases
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.
Switching to SB4 versus Continuation of Etanercept Reference in Patients with Rheumatoid Arthritis and Low Disease Activity
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.
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Results 1 - 10 of 30
Results 1 - 10 of 30