OOIR: Observatory of International Research

Papers

(The median citation count of Biodrugs is 6. 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 2022-08-01 to 2026-08-01.)

Article	Citations
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond	371
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis	337
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy	140
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor	116
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	101
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	100
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome	81
New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making	78
Correction: Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials	68
Why Product Drift Is Not an Issue for Biosimilars/Biologics: Start the Same, Stay the Same	63
Acknowledgement to Referees	56
Localised Delivery of Macromolecules to the Large Intestine: Translation to Clinical Trials	47
In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart	44
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	43
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	40
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?	39
Cell Engineering for Increasing Production of Recombinant Proteins in Mammalian Cells	38
Correction: Real-World Use of Dostarlimab Plus Chemotherapy in Advanced or Recurrent Endometrial Cancer: A Nationwide Cohort Study in France	38
The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis	36
Effectiveness of Lebrikizumab Treatment for Patients with Atopic Dermatitis Switched from Dupilumab or Tralokinumab: A 48-Week Real-World Retrospective Study	36
Gene Therapy Strategies for Uveal Melanoma: Adeno-associated Virus Delivery Challenges and Translational Opportunities	35
Progress and Challenges in the Treatment of Fabry Disease	34
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase	34
Correction: Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	34
Malaria Vaccines: Progress to Date	32

Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer	31
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?	30
Pharmacokinetics, Safety, and Immunogenicity of a Biosimilar of Nivolumab (LY01015): A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial in Healthy Chinese Male Subjects	29
Interleukin-23 Inhibitors in Inflammatory Bowel Disease	29
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?	28
Real-World Evidence on the Effectiveness and Safety of Spesolimab in the Treatment of Generalized Pustular Psoriasis Flares: A Case Series	28
Acknowledgement to Referees	28
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	27
Interleukin-23 versus Interleukin-17 Inhibitors in Preventing Incidental Psoriatic Arthritis in Patients with Psoriasis: A Real-World Comparison From the TriNetX US Collaborative Network	27
Advanced Combination Therapy in Inflammatory Bowel Disease: What Does the Future Hold?	27
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	25
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review	25
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight	25
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study	24
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics	22
Recombinant Protein Drugs: A 2025 Update	21
Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa	21
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects	21
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis	20
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	20
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review	20
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 Stu	20
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab	19
The Use of Biologics for Thyroid Eye Disease	19
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression	18
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials	18
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database	17
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study	17
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine	17
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies	16
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases	16
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria	16
Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection	16
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs	16
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context	15
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease	15
Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria	14
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	14
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance	14
Patients’ Perceptions of Biosimilars: A Systematic Review	14
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries	13
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study	13
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers	13
Site-Specific Genomic Markers Associated with Outcomes of PD-1 Blockade in Gastric and Esophagogastric Junction Cancer: Analysis of Japan’s C-CAT Registry	12
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method	12
The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases	12
Review of Quality Attributes and Analytical Methods Used for Comparative Analytical Assessment of Monoclonal Antibodies as Part of Successful Biosimilar Approvals in the United States and European Uni	11
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments	11
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins	11
Bidirectional Interplay Between IBD Therapies and the Gut Microbiota: A Pharmacomicrobiomic Approach to Personalized Treatment	11

Advances in Engineered Virus-Like Particles for Genome Editing and Therapy	11
Conditionally Activatable Antibody Platforms: Mechanisms, Modalities, and Clinical Translation Potential	11
Expanding Patient Access to Advanced Therapies	11
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	11
Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure	11
Risankizumab in Patients with Psoriasis with Current or Previous Malignancy: A Multicenter, Retrospective Real-World Study	11
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	11
Antibody-Drug Conjugates in Gynecologic Oncology: Advances, Challenges, and Future Directions	10
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline	10
Correction: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	10
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians	10
Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System	10
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	9
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical	9
Copies of Biological Medicines: Similar But Not the Same?	9
Emerging Innate Immune Cells in Cancer Immunotherapy: Promises and Challenges	9
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	9
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer	9
Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching	9
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region	9
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs	9
Effect of Biological Therapy for Psoriasis on the Development of Psoriatic Arthritis: A Population-Based Cohort Study	9
Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults	8
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer	8
A Population Pharmacokinetic Model of Tocilizumab in Kidney Transplant Patients Treated for Chronic Active Antibody-Mediated Rejection: Comparison of Plasma Exposure Between Intravenous and Subcutaneo	8
Acknowledgement to Referees	8
Progress in Designing Cytokine Antagonist Antibodies for Cancer Therapy	8
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus	8
An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies	8
The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis	8
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines	8
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness	8
Relevance of Neutralizing Antibodies for the Pharmacokinetics of Pegunigalsidase Alfa in Patients with Fabry Disease	8
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	8
Sequelae of B-Cell Depleting Therapy: An Immunologist’s Perspective	8
First-in-Human Study on Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of HEC88473, a Novel Dual GLP-1 and FGF21 Receptor Agonist in Healthy and Obese Chinese Subjects	8
Programmed Cell Death Protein 1-Interleukin-2 Bispecific Agents for Cancer Therapy	7
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data	7
Investigational RNA Interference Agents for Hepatitis B	7
An Overview and Trend Analysis of Biosimilar Approvals in China	7
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases	7
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	7
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	7
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	7
Treatment Targets Should Influence Choice of Infliximab Dose Intensification Strategy in Inflammatory Bowel Disease: A Pharmacokinetic Simulation Study	6
Recent Developments in Lipid Nanoparticle-Mediated Delivery of Biotherapeutics and Gene Therapy Across the Blood–Brain Barrier	6
Current Developments in the Preclinical and Clinical use of Natural Killer T cells	6
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	6
Characterization of a HIR-Fab-IDS, Novel Iduronate 2-Sulfatase Fusion Protein for the Treatment of Neuropathic Mucopolysaccharidosis Type II (Hunter Syndrome)	6
Acknowledgement to Referees	6
Complement Inhibition in Kidney Transplantation: Where Are We Now?	6
Phase I Studies of HLX26, A Novel Anti-LAG-3 Antibody, Monotherapy or Combination Therapy in Patients with Advanced Solid Tumors	6