OOIR: Observatory of International Research

Papers

(The median citation count of Biodrugs is 4. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2020-11-01 to 2024-11-01.)

Article	Citations
Therapeutic siRNA: State-of-the-Art and Future Perspectives	161
Engineered Bacteriophage Therapeutics: Rationale, Challenges and Future	80
Antisense Oligonucleotide Therapy: From Design to the Huntington Disease Clinic	63
Immunogenicity Challenges Associated with Subcutaneous Delivery of Therapeutic Proteins	55
Immunogenicity of Recombinant Adeno-Associated Virus (AAV) Vectors for Gene Transfer	55
Dengue Vaccines: An Update	53
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease	46
Teserpaturev/G47Δ: First Approval	43
European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption	42
Administration of CD4+CD25highCD127−FoxP3+ Regulatory T Cells for Relapsing-Remitting Multiple Sclerosis: A Phase 1 Study	41
Clinical Development of New Antibody–Drug Conjugates in Breast Cancer: To Infinity and Beyond	40
CAR-T Cell Therapy for Acute Myeloid Leukemia: Preclinical Rationale, Current Clinical Progress, and Barriers to Success	38
Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis	37
RNA Targeting and Gene Editing Strategies for Transthyretin Amyloidosis	33
Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities	31
Focused Update on AAV-Based Gene Therapy Clinical Trials for Inherited Retinal Degeneration	30
Recent Achievements and Challenges in Prolonging the Serum Half-Lives of Therapeutic IgG Antibodies Through Fc Engineering	29
Anti-VEGF and Other Novel Therapies for Neovascular Age-Related Macular Degeneration: An Update	27
Novel Targeted Biological Agents for the Treatment of Atopic Dermatitis	27
SARS-CoV-2 Neutralization in Convalescent Plasma and Commercial Lots of Plasma-Derived Immunoglobulin	27
Tumor in the Crossfire: Inhibiting TGF-β to Enhance Cancer Immunotherapy	26
Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants	26
Safety of Intravitreal Gene Therapy for Treatment of Subjects with Leber Hereditary Optic Neuropathy due to Mutations in the Mitochondrial ND4 Gene: The REVEAL Study	25
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale	23
Cryopreservation of NK and T Cells Without DMSO for Adoptive Cell-Based Immunotherapy	23

Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies	23
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	23
Plant-Derived Human Vaccines: Recent Developments	22
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management	22
Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project	21
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience	21
Serplulimab Plus Chemotherapy vs Chemotherapy for Treatment of US and Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: A Cost-Effectiveness Analysis to Inform Drug Pricing	20
Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets	20
New Insight on the Safety of Erenumab: An Analysis of Spontaneous Reports of Adverse Events Recorded in the US Food and Drug Administration Adverse Event Reporting System Database	19
Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe	19
Malaria Vaccines: Progress to Date	19
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)	17
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine	17
Targeting IL-36 in Inflammatory Skin Diseases	17
Vaccine-Associated Enhanced Viral Disease: Implications for Viral Vaccine Development	16
Targeting Co-Stimulatory Receptors of the TNF Superfamily for Cancer Immunotherapy	16
Physician Understanding and Willingness to Prescribe Biosimilars: Findings from a US National Survey	16
A Pharmacological Batch of Mongersen that Downregulates Smad7 is Effective as Induction Therapy in Active Crohn’s Disease: A Phase II, Open-Label Study	16
Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review	15
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, Doub	14
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	14
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	14
Biosimilar Perceptions Among Healthcare Professionals and Commercial Medical Benefit Policy Analysis in the United States	13
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	13
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)	13
Enhancing the Response Rate to Recombinant Uricases in Patients with Gout	13
Impact of Obesity on Response to Biologic Therapies in Patients with Inflammatory Bowel Diseases	13
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design	13
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	12
A Tale of Two New Targets for Hypertriglyceridaemia: Which Choice of Therapy?	12
Outer Membrane Vesicle Vaccine Platforms	12
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines	12
Emerging Targeted Therapies for Neuromyelitis Optica Spectrum Disorders	12
PROTACs: Current Trends in Protein Degradation by Proteolysis-Targeting Chimeras	12
Current and Emerging Targeted Therapies for Acute Graft-Versus-Host Disease	11
Targeting the Inside of Cells with Biologicals: Chemicals as a Delivery Strategy	11
Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics	11
Targeted Therapy for Primary Sjögren’s Syndrome: Where are We Now?	11
Restoring Protein Expression in Neuromuscular Conditions: A Review Assessing the Current State of Exon Skipping/Inclusion and Gene Therapies for Duchenne Muscular Dystrophy and Spinal Muscular Atrophy	10
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 (ADM	10
Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilan	9
Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	9
Comparative Risk of Arterial Thromboembolic Events Between Aflibercept and Ranibizumab in Patients with Maculopathy: A Population-Based Retrospective Cohort Study	9
The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries	9
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	8
Pharmacists’ Perspectives of Biosimilars: A Systematic Review	8
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases	8
CRISPR Takes the Front Seat in CART-Cell Development	8
Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis	8
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus	7

Effect Modification by Indication to the Risks of Major Thromboembolic Adverse Events in Patients Receiving Intravitreal Anti-Vascular Endothelial Growth Factor Treatment: A Population-Based Retrospec	7
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	7
Translational Approach for Predicting Human Pharmacokinetics of Engineered Therapeutic Monoclonal Antibodies with Increased FcRn-Binding Mutations	7
The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland	7
Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective	7
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	7
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine	7
Evolving Perceptions, Utilization, and Real-World Implementation Experiences of Oncology Monoclonal Antibody Biosimilars in the USA: Perspectives from Both Payers and Physicians	7
Payer and Implementation Challenges with Advanced Therapy Medicinal Products (ATMPs)	7
Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis	7
Base Editing and Prime Editing: Potential Therapeutic Options for Rare and Common Diseases	7
Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product	7
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	7
Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans	6
Patients’ Perceptions of Biosimilars: A Systematic Review	6
Targeting Leukocyte Trafficking in Inflammatory Bowel Disease	6
The Economic Burden of CAR T Cell Therapies Ciltacabtagene Autoleucel and Idecabtagene Vicleucel for the Treatment of Adult Patients with Relapsed or Refractory Multiple Myeloma in the US	6
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	6
The Nocebo Effect in a Non-Medical Switching Program from Originator to Biosimilar Infliximab in Inflammatory Bowel Disease	6
Targeting Nuclear Export Proteins in Multiple Myeloma Therapy	6
Complement Inhibition in Kidney Transplantation: Where Are We Now?	6
Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar	6
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance	6
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies	6
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	6
Switching from Biologic to Biosimilar Products: Insight from an Integrated Health Care System	5
Current Developments in the Preclinical and Clinical use of Natural Killer T cells	5
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One	5
Checkpoint Inhibitors in Gynecological Malignancies: Are we There Yet?	5
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	5
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	5
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	5
Maintaining Clinical Freedom Whilst Achieving Value in Biologics Prescribing: An Integrated Cross-Specialty Consensus of UK Dermatologists, Rheumatologists and Gastroenterologists	5
Exploring the Use of Monoclonal Antibodies and Antiviral Therapies for Early Treatment of COVID-19 Outpatients in a Real-World Setting: A Nationwide Study from England and Italy	5
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	5
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	4
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer	4
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	4
Investigational Agents in Development for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration	4
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	4
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context	4
Systematic Review and Principal Components Analysis of the Immunogenicity of Adalimumab	4
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria	4
Biologics and Targeted Synthetic Drugs Can Induce Immune-Mediated Glomerular Disorders in Patients with Rheumatic Diseases: An Updated Systematic Literature Review	4
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies	4
Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review	4
Progress with RNA Interference for the Treatment of Primary Hyperoxaluria	4
Assessment of Reported Adverse Events After Interchanging Between TNF-α Inhibitor Biosimilars in the WHO Pharmacovigilance Database	4
Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicente	4
Home-Based Infusion of Alglucosidase Alfa Can Safely be Implemented in Adults with Late-Onset Pompe Disease: Lessons Learned from 18,380 Infusions	4
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	4
First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data	4