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

Article	Citations
Clinical Features and Drug Retention of TNF Inhibitors in Older Patients with Ankylosing Spondylitis: Results from the KOBIO Registry	301
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond	228
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy	106
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome	105
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor	86
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis	81
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	77
New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making	72
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	61
In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart	52
Acknowledgement to Referees	49
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	45
Localised Delivery of Macromolecules to the Large Intestine: Translation to Clinical Trials	45
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	41
A Tale of Two New Targets for Hypertriglyceridaemia: Which Choice of Therapy?	36
Correction to: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	33
Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies	33
The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis	33
Antisense Oligonucleotide Therapy: From Design to the Huntington Disease Clinic	33
Cell Engineering for Increasing Production of Recombinant Proteins in Mammalian Cells	32
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?	30
Progress and Challenges in the Treatment of Fabry Disease	30
First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data	30
Malaria Vaccines: Progress to Date	30
Correction: Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	30

Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase	30
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?	28
Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer	27
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?	26
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	26
Real-World Evidence on the Effectiveness and Safety of Spesolimab in the Treatment of Generalized Pustular Psoriasis Flares: A Case Series	24
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	23
Enhancing the Response Rate to Recombinant Uricases in Patients with Gout	23
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review	22
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	21
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	21
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience	21
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study	21
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	21
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight	20
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine	20
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	20
Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa	19
Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis	19
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics	18
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects	18
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	17
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review	17
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	17
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database	16
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study	16
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis	16
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression	15
The Use of Biologics for Thyroid Eye Disease	15
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	15
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab	14
Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics	14
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies	14
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials	14
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria	13
Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection	13
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs	12
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance	12
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context	12
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases	12
Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria	12
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine	12
The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases	11
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease	11
Bidirectional Interplay Between IBD Therapies and the Gut Microbiota: A Pharmacomicrobiomic Approach to Personalized Treatment	11
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries	11
Patients’ Perceptions of Biosimilars: A Systematic Review	11
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study	11
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers	11
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	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	10
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	10
Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure	10
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method	10
Conditionally Activatable Antibody Platforms: Mechanisms, Modalities, and Clinical Translation Potential	9
Risankizumab in Patients with Psoriasis with Current or Previous Malignancy: A Multicenter, Retrospective Real-World Study	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
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	9
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments	9
Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	9
Plant-Derived Human Vaccines: Recent Developments	9
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins	9
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians	9
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	9
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	8
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline	8
Correction: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	8
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region	8
Copies of Biological Medicines: Similar But Not the Same?	8
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer	8
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs	8
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical	8
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness	7
An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies	7
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer	7
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
Acknowledgement to Referees	7
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines	7
Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching	7
Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults	7
Neoadjuvant Immune Checkpoint Inhibitor Therapy in Melanoma: Efficacy, Safety and Timing	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
Investigational RNA Interference Agents for Hepatitis B	7
Effect of Biological Therapy for Psoriasis on the Development of Psoriatic Arthritis: A Population-Based Cohort Study	7
Emerging Innate Immune Cells in Cancer Immunotherapy: Promises and Challenges	7
Relevance of Neutralizing Antibodies for the Pharmacokinetics of Pegunigalsidase Alfa in Patients with Fabry Disease	7
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus	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
Acknowledgement to Referees	6
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	6
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	6
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	6
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
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One	6
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data	6
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	6
Treatment Targets Should Influence Choice of Infliximab Dose Intensification Strategy in Inflammatory Bowel Disease: A Pharmacokinetic Simulation Study	6