ReviewBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2016
Assessing the Immunogenicity of Biopharmaceuticals.
Review in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
58 citing papers in PubMed, 1 synthesis or guideline pooled it, 126 citations in OpenAlex.
- Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.PloS one · 2018Pooled it
- Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis.Clinical and experimental immunology · 2018Trial
- Article
- Population pharmacokinetic modeling of adalimumab biosimilar SCT630 and Humira® in healthy participants and patients with moderate to severe plaque psoriasis to establish PK similarity.Current therapeutic research, clinical and experimental · 2026Article
- Inhalable bacteriophage endolysins: a novel therapeutic strategy for drug-resistant bacterial pulmonary infections - a comprehensive review.Annals of medicine · 2026Review
- Minimum Significant Ratio for Defining Treatment-Boosted ADA Responses Using Signal-to-Noise as an Alternative to Titer.The AAPS journal · 2026Article
- Drawing a line in the sand: impact of analytical choices on anti-drug antibody cut-points and testing outcomes.Bioanalysis · 2026Article
- Regulatory and safety challenges of biosimilars: insights from developed and emerging economies.European journal of clinical pharmacology · 2026Review
- Targeted degradation of c-Myc through the midnolin-proteasome pathway.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Nasal Delivery of mRNA Using Thermoresponsive Gellable Aqueous Biphasic Systems.Small (Weinheim an der Bergstrasse, Germany) · 2026Article
- Clinical MAPPs: a personalized healthcare-driven assay for the direct identification of potential T cell epitopes in patients.Frontiers in immunology · 2026Article
- Safety Assessment of Stem Cell-Based Therapies: Current Standards and Advancing Frameworks.Cells · 2025Review
- Impact of drug concentration and ADA assay drug tolerance on the assessment and correlation of titer and signal to noise.Bioanalysis · 2025Article
- Polysaccharide Hydrogels as Delivery Platforms for Natural Bioactive Molecules: From Tissue Regeneration to Infection Control.Gels (Basel, Switzerland) · 2025Review
- A single point mutation on FLT3L-Fc protein increases the risk of immunogenicity.Frontiers in immunology · 2025Article
- Assessment of antigen-specific T cell recall responses in non-human primates using a composite AIM assay.Frontiers in immunology · 2025Article
- Exosome engineering for targeted therapy of brain-infecting pathogens: molecular tools, delivery platforms, and translational advances.Frontiers in medical technology · 2025Review
- Simultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS.Bioanalysis · 2025Article
- Mechanism of Action and Pharmacokinetics of Approved Bispecific Antibodies.Biomolecules & therapeutics · 2024Review
- What to Expect When Switching to a Biosimilar: A US Healthcare Professional's Perspective.Crohn's & colitis 360 · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biopharmaceuticals have the potential to raise an immunogenic response in treated individuals, which may impact the efficacy and safety profile of these drugs. As a result, it is essential to evaluate immunogenicity throughout the different phases of the clinical development of a biopharmaceutical, including post-marketing surveillance. Although rigorous evaluation of biopharmaceutical immunogenicity is required by regulatory authorities, there is a lack of uniform standards for the type, quantity, and quality of evidence, and for guidance on experimental design for immunogenicity assays or criteria to compare immunogenicity of biopharmaceuticals. Moreover, substantial technological advances in methods to assess immune responses have yielded higher immunogenicity rates with modern assays, and limit comparison of immunogenicity of biopharmaceuticals outside of head-to-head clinical trials. Accordingly, research programs, regulatory agencies, and clinicians need to keep pace with continuously evolving analyses of immunogenicity. Here, we review factors associated with immunogenicity of biopharmaceuticals, potential clinical ramifications, and current regulatory guidance for evaluating immunogenicity, and discuss methods to assess immunogenicity in non-clinical and clinical studies. We also describe special considerations for evaluating the immunogenicity of biosimilar candidates.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.