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 2021-11-01 to 2025-11-01.)

Article	Citations
Clinical Features and Drug Retention of TNF Inhibitors in Older Patients with Ankylosing Spondylitis: Results from the KOBIO Registry	286
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond	204
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis	98
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome	96
New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making	82
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy	74
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	72
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	60
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design	59
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor	57
In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart	48
Antisense Oligonucleotide Therapy: From Design to the Huntington Disease Clinic	46
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	42
Acknowledgement to Referees	40
Localised Delivery of Macromolecules to the Large Intestine: Translation to Clinical Trials	36
Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies	33
A Tale of Two New Targets for Hypertriglyceridaemia: Which Choice of Therapy?	33
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	32
Correction to: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	31
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?	31
Correction: Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	30
The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis	30
First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data	28
Malaria Vaccines: Progress to Date	27
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?	27

Progress and Challenges in the Treatment of Fabry Disease	27
Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer	27
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase	27
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
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?	25
Real-World Evidence on the Effectiveness and Safety of Spesolimab in the Treatment of Generalized Pustular Psoriasis Flares: A Case Series	23
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review	23
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	21
Enhancing the Response Rate to Recombinant Uricases in Patients with Gout	21
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	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
Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa	20
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study	20
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience	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
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine	19
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
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics	17
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	17
Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis	17
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	16
The Use of Biologics for Thyroid Eye Disease	16
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review	16
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	16
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study	16
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight	16
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials	15
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis	15
Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics	15
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database	14
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab	14
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression	14
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies	14
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs	13
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine	13
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria	13
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases	13
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context	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
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance	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	11
Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria	11
Patients’ Perceptions of Biosimilars: A Systematic Review	11
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease	11
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries	10
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method	10
Bidirectional Interplay Between IBD Therapies and the Gut Microbiota: A Pharmacomicrobiomic Approach to Personalized Treatment	10
Plant-Derived Human Vaccines: Recent Developments	9
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians	9

The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases	9
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	9
Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure	9
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study	9
Risankizumab in Patients with Psoriasis with Current or Previous Malignancy: A Multicenter, Retrospective Real-World Study	9
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments	9
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
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region	8
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	8
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer	8
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins	8
Correction: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	8
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical	8
Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	8
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	8
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline	8
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	8
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs	7
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness	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
Copies of Biological Medicines: Similar But Not the Same?	7
Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching	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
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
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
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer	7
An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies	7
Acknowledgement to Referees	6
Investigational RNA Interference Agents for Hepatitis B	6
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One	6
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	6
Acknowledgement to Referees	6
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	6
Sequelae of B-Cell Depleting Therapy: An Immunologist’s Perspective	6
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	6
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data	6
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases	6
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	6
Evolving Perceptions, Utilization, and Real-World Implementation Experiences of Oncology Monoclonal Antibody Biosimilars in the USA: Perspectives from Both Payers and Physicians	6
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	6
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines	6
Postmarketing Reports of Incomplete Dosing-Related Complications with Self-Injected PCSK9 Inhibitors: A Descriptive Study and Disproportionality Analysis	6
Treatment Targets Should Influence Choice of Infliximab Dose Intensification Strategy in Inflammatory Bowel Disease: A Pharmacokinetic Simulation Study	6
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	6
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	6