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 2022-05-01 to 2026-05-01.)

Article	Citations
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond	339
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis	281
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	122
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy	116
New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making	99
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome	90
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor	90
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	76
Acknowledgement to Referees	60
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	60
Localised Delivery of Macromolecules to the Large Intestine: Translation to Clinical Trials	60
In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart	45
Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies	44
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	40
The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis	39
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?	36
Cell Engineering for Increasing Production of Recombinant Proteins in Mammalian Cells	36
Correction: Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	35
Effectiveness of Lebrikizumab Treatment for Patients with Atopic Dermatitis Switched from Dupilumab or Tralokinumab: A 48-Week Real-World Retrospective Study	34
Malaria Vaccines: Progress to Date	33
Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer	33
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase	33
Progress and Challenges in the Treatment of Fabry Disease	33
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?	32
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	32

Interleukin-23 Inhibitors in Inflammatory Bowel Disease	32
Real-World Evidence on the Effectiveness and Safety of Spesolimab in the Treatment of Generalized Pustular Psoriasis Flares: A Case Series	30
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	30
Acknowledgement to Referees	30
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review	29
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	28
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?	27
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience	26
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	24
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight	24
Advanced Combination Therapy in Inflammatory Bowel Disease: What Does the Future Hold?	24
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	24
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study	23
Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis	23
Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa	23
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine	23
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects	21
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics	21
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	19
Tolerability and Reactogenicity Profile of mRNA SARS-Cov-2 Vaccines from a Mass Vaccination Campaign in a Tertiary Hospital: Between-Vaccine and Between-Population Prospective Observational Study (Vig	19
HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Heal	18
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials	18
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study	18
The Use of Biologics for Thyroid Eye Disease	18
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression	18
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis	18
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab	18
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review	17
Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection	17
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database	17
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases	16
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs	16
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria	16
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies	16
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine	14
Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria	14
Patients’ Perceptions of Biosimilars: A Systematic Review	13
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context	13
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance	13
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries	12
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers	12
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study	12
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease	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
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	12
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
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments	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

Site-Specific Genomic Markers Associated with Outcomes of PD-1 Blockade in Gastric and Esophagogastric Junction Cancer: Analysis of Japan’s C-CAT Registry	11
Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure	11
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins	11
Plant-Derived Human Vaccines: Recent Developments	10
Conditionally Activatable Antibody Platforms: Mechanisms, Modalities, and Clinical Translation Potential	10
Risankizumab in Patients with Psoriasis with Current or Previous Malignancy: A Multicenter, Retrospective Real-World Study	10
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians	10
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	9
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer	9
Antibody-Drug Conjugates in Gynecologic Oncology: Advances, Challenges, and Future Directions	9
Correction: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	9
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	9
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical	9
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region	9
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	9
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	9
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs	8
Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching	8
An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies	8
Effect of Biological Therapy for Psoriasis on the Development of Psoriatic Arthritis: A Population-Based Cohort Study	8
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline	8
Emerging Innate Immune Cells in Cancer Immunotherapy: Promises and Challenges	8
Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults	8
Copies of Biological Medicines: Similar But Not the Same?	8
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness	8
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus	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	7
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer	7
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One	7
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	7
Progress in Designing Cytokine Antagonist Antibodies for Cancer Therapy	7
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	7
Sequelae of B-Cell Depleting Therapy: An Immunologist’s Perspective	7
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines	7
Treatment Targets Should Influence Choice of Infliximab Dose Intensification Strategy in Inflammatory Bowel Disease: A Pharmacokinetic Simulation Study	7
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data	7
Relevance of Neutralizing Antibodies for the Pharmacokinetics of Pegunigalsidase Alfa in Patients with Fabry Disease	7
The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis	7
Investigational RNA Interference Agents for Hepatitis B	7
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	7
Programmed Cell Death Protein 1-Interleukin-2 Bispecific Agents for Cancer Therapy	7
Acknowledgement to Referees	7
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	7
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases	6
Postmarketing Reports of Incomplete Dosing-Related Complications with Self-Injected PCSK9 Inhibitors: A Descriptive Study and Disproportionality Analysis	6
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	6
Acknowledgement to Referees	6
Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management	6
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	6
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management	6
Current Developments in the Preclinical and Clinical use of Natural Killer T cells	6