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 2021-04-01 to 2025-04-01.)

Article	Citations
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review	207
Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review	107
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies	92
Outer Membrane Vesicle Vaccine Platforms	79
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases	74
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	65
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries	51
Investigational Agents in Development for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration	48
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies	47
Treatment Targets Should Influence Choice of Infliximab Dose Intensification Strategy in Inflammatory Bowel Disease: A Pharmacokinetic Simulation Study	45
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins	41
Evolving Perceptions, Utilization, and Real-World Implementation Experiences of Oncology Monoclonal Antibody Biosimilars in the USA: Perspectives from Both Payers and Physicians	33
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience	31
Enhancing the Response Rate to Recombinant Uricases in Patients with Gout	31
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia	30
Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study (STELLA)	30
Clinical Features and Drug Retention of TNF Inhibitors in Older Patients with Ankylosing Spondylitis: Results from the KOBIO Registry	30
Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	29
Plant-Derived Human Vaccines: Recent Developments	28
The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland	27
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association	27
Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial	27
Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data	27
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options	26
Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis	25

Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans	24
Extracellular Vesicles Derived from Mesenchymal Stem Cells: A Potential Biodrug for Acute Respiratory Distress Syndrome Treatment	23
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	22
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond	22
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?	21
Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	20
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies	19
The Evolving Applications of Bispecific Antibodies: Reaping the Harvest of Early Sowing and Planting New Seeds	19
Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar	19
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments	19
Translational Approach for Predicting Human Pharmacokinetics of Engineered Therapeutic Monoclonal Antibodies with Increased FcRn-Binding Mutations	18
RNA Targeting and Gene Editing Strategies for Transthyretin Amyloidosis	17
Targeting the Inside of Cells with Biologicals: Chemicals as a Delivery Strategy	17
Immunogenicity of Recombinant Adeno-Associated Virus (AAV) Vectors for Gene Transfer	17
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One	17
Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab	16
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects	15
New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making	15
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome	15
A Pharmacological Batch of Mongersen that Downregulates Smad7 is Effective as Induction Therapy in Active Crohn’s Disease: A Phase II, Open-Label Study	14
Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis	14
Complement Inhibition in Kidney Transplantation: Where Are We Now?	14
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	14
Could a Long-Acting Prodrug of SN-38 be Efficacious in Sacituzumab Govitecan-Resistant Tumors?	14
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study	14
Acknowledgement to Referees	14
Targeting Co-Stimulatory Receptors of the TNF Superfamily for Cancer Immunotherapy	13
Correction: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy	13
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical	12
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery	12
Characterization of a HIR-Fab-IDS, Novel Iduronate 2-Sulfatase Fusion Protein for the Treatment of Neuropathic Mucopolysaccharidosis Type II (Hunter Syndrome)	12
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region	11
Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems	11
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor	11
Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer	11
Home-Based Infusion of Alglucosidase Alfa Can Safely be Implemented in Adults with Late-Onset Pompe Disease: Lessons Learned from 18,380 Infusions	11
Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab	10
Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa	10
Current Developments in the Preclinical and Clinical use of Natural Killer T cells	10
Novel Immunotherapeutic Approaches for the Treatment of Glioblastoma	10
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer	10
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	10
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight	9
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis	9
Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management	9
Postmarketing Reports of Incomplete Dosing-Related Complications with Self-Injected PCSK9 Inhibitors: A Descriptive Study and Disproportionality Analysis	8
Comment on: “Safety of Marketed Cancer Supportive Care Biosimilars in the U.S.: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database”	8
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management	8
Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product	8
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine	8

Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis	8
Systematic Literature Review of Economic Evaluations of Treatment Alternatives in Chronic Lymphocytic Leukemia	8
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	7
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog®) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Labe	7
Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Tria	7
Base Editing and Prime Editing: Potential Therapeutic Options for Rare and Common Diseases	7
Targeting IL-36 in Inflammatory Skin Diseases	7
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	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
The Role of Biologics in the Treatment of Chronic Rhinosinusitis	7
Comparative Treatment Persistence with Bone-Targeting Agents Among Asian Patients with Bone Metastases from Solid Tumors: A Multinational Retrospective Cohort Study	7
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	7
Author’s Reply to Joerg Putzke et al. Comment on: “Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event R	7
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs	7
Targeting Nuclear Export Proteins in Multiple Myeloma Therapy	6
Targeted Therapy for Primary Sjögren’s Syndrome: Where are We Now?	6
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale	6
Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicente	6
Antibody-Drug Conjugates as Novel Therapeutic Agents for Non-Small Cell Lung Carcinoma with or without Alterations in Oncogenic Drivers	6
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design	6
Novel Targeted Biological Agents for the Treatment of Atopic Dermatitis	6
Stem Cells and Stem Cell-Derived Factors for the Treatment of Inflammatory Bowel Disease with a Particular Focus on Perianal Fistulizing Disease: A Minireview on Future Perspectives	6
A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn’s Disease	6
Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators	6
Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants	6
SARS-CoV-2 Neutralization in Convalescent Plasma and Commercial Lots of Plasma-Derived Immunoglobulin	6
Localised Delivery of Macromolecules to the Large Intestine: Translation to Clinical Trials	5
Copies of Biological Medicines: Similar But Not the Same?	5
CAR-T Cells and the Kidney: Insights from the WHO Safety Database	5
A Tale of Two New Targets for Hypertriglyceridaemia: Which Choice of Therapy?	5
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	5
Switching from Biologic to Biosimilar Products: Insight from an Integrated Health Care System	5
Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial	5
Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics	5
Advances in Immunotherapy for Diffuse Large B Cell Lymphoma	5
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis	5
Eblasakimab, an Anti-IL‑13Rα1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate‑to‑Severe Atopic Dermatitis	4
In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart	4
Biosimilar Policies and Their Impact on Market Penetration of Adalimumab, Etanercept and Infliximab: A Policy Synthesis and Descriptive Analysis in 13 OECD Countries	4
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review	4
Recombinant Antibody Fragments for Immunotherapy of Parkinson’s Disease	4
Systematic Review of Genetic Substrate Reduction Therapy in Lysosomal Storage Diseases: Opportunities, Challenges and Delivery Systems	4
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	4
Emerging Innate Immune Cells in Cancer Immunotherapy: Promises and Challenges	4
Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review	4
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study	4
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database	4
Effect of Biological Therapy for Psoriasis on the Development of Psoriatic Arthritis: A Population-Based Cohort Study	4
Tumor in the Crossfire: Inhibiting TGF-β to Enhance Cancer Immunotherapy	4
Can Endangered Biosimilar Markets be Rescued? The Need to Bridge Competing Interests for Long-Term Gain	4
Accelerating CAR-T Cell Therapies with Small-Molecule Inhibitors	4
Acknowledgement to Referees	4
Primary and Acquired Resistance to Immunotherapy with Checkpoint Inhibitors in NSCLC: From Bedside to Bench and Back	4
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022	4
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness	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