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Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
The aim was to assess the influence of the presence of biosimilar adalimumab on adalimumab budget savings in 14 high- and ...
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
The use of different pathways in the treatment of rheumatoid arthritis has led to a significant decrease in the number of ...
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
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
CT-P43 is a candidate ustekinumab biosimilar in clinical development. This paper aims to demonstrate equivalent efficacy o...
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
The interleukin-2 (IL-2) cytokine plays a crucial role in regulating immune responses and maintaining immune homeostasis. ...
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Duchenne muscular dystrophy is a devastating disease that leads to progressive muscle loss and premature death. While medi...
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease
Two monoclonal antibodies (mAbs), aducanumab and lecanemab, have received accelerated approval from the US FDA for initiat...
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies
Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are vascular diseases with high prevalence, ranking a...
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval...
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access
In recent years, subcutaneous administration of biotherapeutics has made significant progress. The self-administration mar...
Outer Membrane Vesicle Vaccine Platforms
Outer Membrane Vesicle Vaccine Platforms
Outer membrane vesicles (OMVs) are spontaneously released by many gram-negative bacteria during their growth and constitut...
Immunotherapy Guided by Immunohistochemistry PD-L1 Testing for Patients with NSCLC: A Microsimulation Model-Based Effectiveness and Cost-Effectiveness Analysis
Immunotherapy Guided by Immunohistochemistry PD-L1 Testing for Patients with NSCLC: A Microsimulation Model-Based Effectiveness and Cost-Effectiveness Analysis
On the basis of immunohistochemistry PD-L1 testing results, patients with advanced non-small cell lung cancer (NSCLC) are ...
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Ixekizumab, an interleukin-17A inhibitor, was efficacious and well tolerated for the treatment of active radiographic axia...
Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer
Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer
Bevacizumab-awwb was the first biosimilar approved for cancer treatment in the USA. Limited information is available on th...
Malaria Vaccines: Progress to Date
Malaria Vaccines: Progress to Date
Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium. Despite significant declines in...
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical
Over the past few years, there has been a surge in the industrial production of recombinant enzymes from microorganisms du...
Patients’ Perceptions of Biosimilars: A Systematic Review
Patients’ Perceptions of Biosimilars: A Systematic Review
To systematically summarize and evaluate the findings of existing studies about patients’ perceptions of biosimilars...
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Several observational studies have reported acute kidney injury from intravitreal anti-vascular endothelial growth factor ...
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
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
The non-interventional PROPER study generated real-world evidence on clinical outcomes following transition in routine pra...
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer
Immune checkpoint blockade (ICB) has improved outcomes for patients with advanced non-small cell lung carcinoma (NSCLC). B...
Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective
Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective
Biosimilars have been available in the USA for over a decade, and in Europe for almost two decades. In that time, biosimil...
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies
Clostridioides difficile is one of the most important causes of healthcare-associated diarrhea. The high incidenc...
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments
The complement system is a crucial part of the innate immune response, providing defense against invading pathogens and ca...
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia
Hemophilia is characterized by a deficiency in coagulation factors VIII or IX. The general standard of care for severe hem...
Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management
Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management
In recent years, machine learning (ML) techniques have garnered considerable interest for their potential use in accelerat...
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data
Behçet’s disease (BD) is a variable vessel vasculitis. Biologic drugs are increasingly used in the treatment of...
The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases
The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases
Janus kinase inhibitor (JAKi) medications are small-molecule drugs that affect intracellular signal transduction. They are...
Home-Based Infusion of Alglucosidase Alfa Can Safely be Implemented in Adults with Late-Onset Pompe Disease: Lessons Learned from 18,380 Infusions
Home-Based Infusion of Alglucosidase Alfa Can Safely be Implemented in Adults with Late-Onset Pompe Disease: Lessons Learned from 18,380 Infusions
Enzyme replacement therapy (ERT) with alglucosidase alfa is the treatment for patients with Pompe disease, a hereditary me...
Base Editing and Prime Editing: Potential Therapeutic Options for Rare and Common Diseases
Base Editing and Prime Editing: Potential Therapeutic Options for Rare and Common Diseases
Collectively, genetic disorders affect approximately 350 million individuals worldwide and are a major global health burde...
The Role of Biologics in the Treatment of Chronic Rhinosinusitis
The Role of Biologics in the Treatment of Chronic Rhinosinusitis
The last decade has seen significant developments in the field of biologics for the treatment of chronic rhinosinusitis wi...
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria
Multidrug-resistant (MDR) bacteria are considered a health threat worldwide, and this problem is set to increase over the ...
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