Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study
Authors (first, second and last of 23)
Collection
Biosimilar Studies
A collection of recent original research articles on biosimilars
Articles (79 in this collection)
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Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
Authors (first, second and last of 8)
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Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer
Authors (first, second and last of 8)
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The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune‐Mediated Inflammatory Disease
Authors (first, second and last of 11)
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In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart
Authors (first, second and last of 7)
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Assessment of Reported Adverse Events After Interchanging Between TNF-α Inhibitor Biosimilars in the WHO Pharmacovigilance Database
Authors (first, second and last of 8)
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Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study
Authors (first, second and last of 11)
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Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method
Authors (first, second and last of 8)
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Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans
Authors (first, second and last of 5)
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Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis
Authors (first, second and last of 18)
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Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial
Authors (first, second and last of 16)
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Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System
Authors (first, second and last of 4)
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Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial
Authors (first, second and last of 21)
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Consistency of Product Quality for SB5, an Adalimumab Biosimilar
Authors (first, second and last of 4)
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The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries
Authors (first, second and last of 5)
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Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial
Authors (first, second and last of 14)
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Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial
Authors (first, second and last of 13)
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Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog®) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study
Authors (first, second and last of 10)
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Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study
Authors (first, second and last of 6)
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The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland
Authors (first, second and last of 4)
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HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects
Authors (first, second and last of 10)
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Embracing Change: An International Survey Study on the Beliefs and Attitudes of Pediatric Rheumatologists Towards Biosimilars
Authors (first, second and last of 7)
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Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe
Authors (first, second and last of 5)
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Long-Term Safety and Effectiveness of PF-05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2-Positive Metastatic Breast Cancer: Updated Results of a Randomized, Double-Blind Study
Authors (first, second and last of 12)
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Incidence of and Reasons and Determinants Associated with Retransitioning from Biosimilar Etanercept to Originator Etanercept
Authors (first, second and last of 6)
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Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study
Authors (first, second and last of 13)
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Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product
Authors (first, second and last of 6)
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Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC)
Authors (first, second and last of 16)
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Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar
Authors (first, second and last of 7)
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Efficacy, Safety, and Immunogenicity of HLX04 Versus Reference Bevacizumab in Combination with XELOX or mFOLFOX6 as First-Line Treatment for Metastatic Colorectal Cancer: Results of a Randomized, Double-Blind Phase III Study
Authors (first, second and last of 17)
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Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis
Authors (first, second and last of 7)
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Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study (STELLA)
Authors (first, second and last of 20)
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Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators
Authors (first, second and last of 7)
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Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial
Authors (first, second and last of 16)
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Physician Understanding and Willingness to Prescribe Biosimilars: Findings from a US National Survey
Authors (first, second and last of 7)
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Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS)
Authors (first, second and last of 10)
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Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database
Authors (first, second and last of 4)
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Biosimilar Perceptions Among Healthcare Professionals and Commercial Medical Benefit Policy Analysis in the United States
Authors (first, second and last of 4)
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A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales - A Mixed Methods Study
Authors (first, second and last of 8)
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European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption
Authors (first, second and last of 4)
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Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study
Authors (first, second and last of 12)
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European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice
Authors (first, second and last of 4)
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Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
Authors (first, second and last of 29)
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Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry
Authors (first, second and last of 5)
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Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study
Authors (first, second and last of 6)
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Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial
Authors (first, second and last of 30)
