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Interrogation of Structure–Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation
Interrogation of Structure–Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation
Recombinant immunoglobulin G2 (IgG2) antibodies are effective neutralization agents or antagonists with high medical value...
Progress and Challenges in the Treatment of Fabry Disease
Progress and Challenges in the Treatment of Fabry Disease
Fabry disease is a rare but life-threatening, X-linked, inherited lysosomal storage disorder in which globotriaosylceramid...
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase
Promoting the use of biosimilars is a global issue from the perspective of reducing medical costs. In Japan, the replaceme...
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?
To evaluate the impact of demand- and supply-side policies on the biosimilar market penetration and identify effective str...
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy
Osteoarthritis is a prevalent condition among middle-aged and elderly populations characterized primarily by the progressi...
Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings
Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings
The introduction of biosimilars into healthcare systems globally is recognized by many as a healthcare success. Despite th...
The Use of Biologics for Thyroid Eye Disease
The Use of Biologics for Thyroid Eye Disease
Thyroid eye disease (TED) is the most common extrathyroidal manifestation of Graves’ disease. It is an autoimmune di...
Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders
Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders
Neuromyelitis optica spectrum disorder (NMOSD) is a rare, autoimmune disease that results in recurring, often severe attac...
Influence of Pharmacokinetic-Pharmacodynamic Failure Mechanisms on Outcomes in Biologic Therapy Sequencing in Inflammatory Bowel Disease: A Retrospective Cohort Study
Influence of Pharmacokinetic-Pharmacodynamic Failure Mechanisms on Outcomes in Biologic Therapy Sequencing in Inflammatory Bowel Disease: A Retrospective Cohort Study
Increasing therapeutic options for inflammatory bowel disease calls for tools to aid choice of sequencing. We investigated...
Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State−of−the−Art Review
Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State−of−the−Art Review
Despite the modern era of effective and safe high-intensity statins and non-statin agents, a significant portion of patien...
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Comparative immunogenicity is a key regulatory requirement for biosimilars. In a streamlined biosimilar development proces...
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline
Since blinatumomab’s approval as the first bispecific antibody (BsAb) in cancer therapy, these immunomodulatory agen...
Individual Prescribing Incentives for Biosimilars in Selected European Countries and the USA: a Scoping Literature Review
Individual Prescribing Incentives for Biosimilars in Selected European Countries and the USA: a Scoping Literature Review
The uptake of biosimilar medicines in Europe and the USA remains highly variable and at times slow, despite the significan...
Comprehensive Physico-Chemical and Functional Similarity Assessment of Intravenous and Subcutaneous RGB-19 Drug Products as Proposed Biosimilars to Tocilizumab Reference Product
Comprehensive Physico-Chemical and Functional Similarity Assessment of Intravenous and Subcutaneous RGB-19 Drug Products as Proposed Biosimilars to Tocilizumab Reference Product
Tocilizumab is a recombinant, humanised monoclonal antibody of the immunoglobulin G1 (IgG1) subclass, which specifically t...
Comprehensive Physico-chemical and Functional Similarity Assessment Study of RGB-14-P and RGB-14-X Drug Products as Proposed Biosimilars to Denosumab Reference Products
Comprehensive Physico-chemical and Functional Similarity Assessment Study of RGB-14-P and RGB-14-X Drug Products as Proposed Biosimilars to Denosumab Reference Products
Denosumab is a fully human monoclonal antibody (IgG2) k subclass that targets and binds with high affinity and specificity...
Introduction of Biopharmaceuticals in Europe: A Cross-Sectional Study of Early Diffusion Patterns and Data Availability
Introduction of Biopharmaceuticals in Europe: A Cross-Sectional Study of Early Diffusion Patterns and Data Availability
Biopharmaceuticals add value in the treatment of many diseases but different health systems in Europe face clinical and ec...
Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
Advanced therapy medicinal products (ATMPs) often require long-term monitoring to assess both safety and efficacy post-aut...
Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation
Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation
Anti-CD20 monoclonal antibodies are gaining clinical relevance in the nephrology community due to their demonstrated effic...
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to Augu...
Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly
Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly
To evaluate the pricing of etanercept (ETN) reference and biosimilar drugs in a changing competitive to monopolized market...
Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Tocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800 (toc...
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases
The screening of antigen-specific B cells has been pivotal for biotherapeutic development for over four decades. Conventio...
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
Antisense oligonucleotides (ASOs) are single stranded nucleic acids that target RNA. The US Food and Drug Administration h...
Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review
Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review
Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by...
Stem Cells and Stem Cell-Derived Factors for the Treatment of Inflammatory Bowel Disease with a Particular Focus on Perianal Fistulizing Disease: A Minireview on Future Perspectives
Stem Cells and Stem Cell-Derived Factors for the Treatment of Inflammatory Bowel Disease with a Particular Focus on Perianal Fistulizing Disease: A Minireview on Future Perspectives
Inflammatory bowel disease remains a difficult disease to effectively treat, especially fistulizing Crohn’s disease....
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond
Mucopolysaccharidosis type II (MPS II) is a rare, pediatric, neurometabolic disorder due to the lack of activity of the ly...
Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial
Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial
Stapokibart/CM310, a humanized monoclonal antibody targeting the interleukin-4 receptor α chain, has shown promising ...
Insulin Icodec: First Approval
Insulin Icodec: First Approval
Insulin icodec (AWIQLI®) is an ultra-long-acting basal insulin analogue that is being developed by Novo Nordisk for t...
Systematic Review of Genetic Substrate Reduction Therapy in Lysosomal Storage Diseases: Opportunities, Challenges and Delivery Systems
Systematic Review of Genetic Substrate Reduction Therapy in Lysosomal Storage Diseases: Opportunities, Challenges and Delivery Systems
Genetic substrate reduction therapy (gSRT), which involves the use of nucleic acids to downregulate the genes involved in ...
A Population Pharmacokinetic Model of Tocilizumab in Kidney Transplant Patients Treated for Chronic Active Antibody-Mediated Rejection: Comparison of Plasma Exposure Between Intravenous and Subcutaneous Administration Schemes
A Population Pharmacokinetic Model of Tocilizumab in Kidney Transplant Patients Treated for Chronic Active Antibody-Mediated Rejection: Comparison of Plasma Exposure Between Intravenous and Subcutaneous Administration Schemes
Tocilizumab prevents the clinical worsening of chronic active antibody-mediated rejection (CAAMR) in kidney transplant rec...
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