OOIR: Observatory of International Research

Papers

(The median citation count of Biodrugs is 5. 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 2021-09-01 to 2025-09-01.)

Article	Citations
Clinical Features and Drug Retention of TNF Inhibitors in Older Patients with Ankylosing Spondylitis: Results from the KOBIO Registry	262
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond	173
New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making	94
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor	90
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome	79
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	66
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis	63
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy	56
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design	51
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	45
Acknowledgement to Referees	44
Localised Delivery of Macromolecules to the Large Intestine: Translation to Clinical Trials	42
A Tale of Two New Targets for Hypertriglyceridaemia: Which Choice of Therapy?	36
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	36
In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart	34
Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies	33
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	32
Correction to: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	31
Antisense Oligonucleotide Therapy: From Design to the Huntington Disease Clinic	31
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?	30
Correction: Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	30
Progress and Challenges in the Treatment of Fabry Disease	29
Malaria Vaccines: Progress to Date	29
First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data	27
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase	27

Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?	26
Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer	26
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience	25
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	25
Real-World Evidence on the Effectiveness and Safety of Spesolimab in the Treatment of Generalized Pustular Psoriasis Flares: A Case Series	24
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review	23
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?	23
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	22
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	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	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
Enhancing the Response Rate to Recombinant Uricases in Patients with Gout	20
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine	19
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics	19
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight	19
Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis	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	18
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study	18
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects	17
Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa	16
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	16
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	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
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
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study	15
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review	15
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials	15
The Use of Biologics for Thyroid Eye Disease	15
Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics	14
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression	14
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database	14
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis	13
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases	13
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab	13
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria	13
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine	12
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs	12
Patients’ Perceptions of Biosimilars: A Systematic Review	12
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies	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
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context	12
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance	12
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease	12
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries	11
The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases	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
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	10
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study	10
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians	10

Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure	10
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	10
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method	10
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	9
Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	9
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins	9
Plant-Derived Human Vaccines: Recent Developments	9
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer	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
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region	8
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs	8
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	8
Correction: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	8
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline	8
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
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical	8
Effect of Biological Therapy for Psoriasis on the Development of Psoriatic Arthritis: A Population-Based Cohort Study	7
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness	7
Copies of Biological Medicines: Similar But Not the Same?	7
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus	7
Emerging Innate Immune Cells in Cancer Immunotherapy: Promises and Challenges	7
An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies	7
Relevance of Neutralizing Antibodies for the Pharmacokinetics of Pegunigalsidase Alfa in Patients with Fabry Disease	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
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
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer	7
Neoadjuvant Immune Checkpoint Inhibitor Therapy in Melanoma: Efficacy, Safety and Timing	7
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	6
Acknowledgement to Referees	6
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines	6
Evolving Perceptions, Utilization, and Real-World Implementation Experiences of Oncology Monoclonal Antibody Biosimilars in the USA: Perspectives from Both Payers and Physicians	6
Anti-VEGF and Other Novel Therapies for Neovascular Age-Related Macular Degeneration: An Update	6
Sequelae of B-Cell Depleting Therapy: An Immunologist’s Perspective	6
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One	6
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	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
Investigational RNA Interference Agents for Hepatitis B	6
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	6
Treatment Targets Should Influence Choice of Infliximab Dose Intensification Strategy in Inflammatory Bowel Disease: A Pharmacokinetic Simulation Study	6
Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings	5
Current Developments in the Preclinical and Clinical use of Natural Killer T cells	5
Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management	5
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	5
Postmarketing Reports of Incomplete Dosing-Related Complications with Self-Injected PCSK9 Inhibitors: A Descriptive Study and Disproportionality Analysis	5
Characterization of a HIR-Fab-IDS, Novel Iduronate 2-Sulfatase Fusion Protein for the Treatment of Neuropathic Mucopolysaccharidosis Type II (Hunter Syndrome)	5
Recombinant Antibody Fragments for Immunotherapy of Parkinson’s Disease	5
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data	5
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	5
Complement Inhibition in Kidney Transplantation: Where Are We Now?	5
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management	5
A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn’s Disease	5
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases	5
Acknowledgement to Referees	5