OOIR: Observatory of International Research

Papers

(The median citation count of Biodrugs is 4. 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 2021-05-01 to 2025-05-01.)

Article	Citations
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond	223
Clinical Features and Drug Retention of TNF Inhibitors in Older Patients with Ankylosing Spondylitis: Results from the KOBIO Registry	119
Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	83
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor	75
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	69
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis	55
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome	50
New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making	48
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design	48
A Tale of Two New Targets for Hypertriglyceridaemia: Which Choice of Therapy?	35
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	33
Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies	32
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	31
Antisense Oligonucleotide Therapy: From Design to the Huntington Disease Clinic	31
In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart	30
Acknowledgement to Referees	30
Localised Delivery of Macromolecules to the Large Intestine: Translation to Clinical Trials	29
Correction to: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	29
First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data	28
Correction: Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	28
Malaria Vaccines: Progress to Date	27
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance	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	24
Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer	24
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

Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?	24
Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis	22
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience	22
Enhancing the Response Rate to Recombinant Uricases in Patients with Gout	21
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	21
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	20
Real-World Evidence on the Effectiveness and Safety of Spesolimab in the Treatment of Generalized Pustular Psoriasis Flares: A Case Series	20
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight	19
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?	19
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	19
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review	19
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	19
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects	19
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
Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis	17
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	17
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine	16
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics	15
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	14
Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa	14
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study	14
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review	14
Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics	14
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials	13
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	13
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab	13
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database	12
Novel Targeted Biological Agents for the Treatment of Atopic Dermatitis	12
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression	12
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis	12
Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria	11
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases	11
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs	11
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease	10
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine	10
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context	10
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
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies	10
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	10
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance	10
Patients’ Perceptions of Biosimilars: A Systematic Review	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	9
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins	9
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries	9
Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure	9
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers	9
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method	9
The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases	9
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians	8
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	8

Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments	8
Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	8
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	8
Plant-Derived Human Vaccines: Recent Developments	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	7
Correction: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	7
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness	7
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical	7
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs	7
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer	7
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region	7
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	7
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	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	6
An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies	6
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer	6
Relevance of Neutralizing Antibodies for the Pharmacokinetics of Pegunigalsidase Alfa in Patients with Fabry Disease	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
Cryopreservation of NK and T Cells Without DMSO for Adoptive Cell-Based Immunotherapy	6
Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching	6
Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults	6
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus	6
Anti-VEGF and Other Novel Therapies for Neovascular Age-Related Macular Degeneration: An Update	6
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review	6
Copies of Biological Medicines: Similar But Not the Same?	6
Neoadjuvant Immune Checkpoint Inhibitor Therapy in Melanoma: Efficacy, Safety and Timing	6
Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC)	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
Acknowledgement to Referees	6
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines	5
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data	5
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	5
Sequelae of B-Cell Depleting Therapy: An Immunologist’s Perspective	5
Evolving Perceptions, Utilization, and Real-World Implementation Experiences of Oncology Monoclonal Antibody Biosimilars in the USA: Perspectives from Both Payers and Physicians	5
Treatment Targets Should Influence Choice of Infliximab Dose Intensification Strategy in Inflammatory Bowel Disease: A Pharmacokinetic Simulation Study	5
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases	5
Investigational RNA Interference Agents for Hepatitis B	5
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	5
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	5
Postmarketing Reports of Incomplete Dosing-Related Complications with Self-Injected PCSK9 Inhibitors: A Descriptive Study and Disproportionality Analysis	4
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	4
Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product	4
A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn’s Disease	4
SARS-CoV-2 Neutralization in Convalescent Plasma and Commercial Lots of Plasma-Derived Immunoglobulin	4
Research Advances in Stem Cell Therapy for Erectile Dysfunction	4
Complement Inhibition in Kidney Transplantation: Where Are We Now?	4
Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management	4
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One	4
Characterization of a HIR-Fab-IDS, Novel Iduronate 2-Sulfatase Fusion Protein for the Treatment of Neuropathic Mucopolysaccharidosis Type II (Hunter Syndrome)	4
Recombinant Antibody Fragments for Immunotherapy of Parkinson’s Disease	4
Acknowledgement to Referees	4
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management	4
Current Developments in the Preclinical and Clinical use of Natural Killer T cells	4
Acknowledgement to Referees	4
Switching from Biologic to Biosimilar Products: Insight from an Integrated Health Care System	4
The Economic Burden of CAR T Cell Therapies Ciltacabtagene Autoleucel and Idecabtagene Vicleucel for the Treatment of Adult Patients with Relapsed or Refractory Multiple Myeloma in the US	4
Assessment of Reported Adverse Events After Interchanging Between TNF-α Inhibitor Biosimilars in the WHO Pharmacovigilance Database	4