ReviewBioanalysis2025
The changes necessary in the assessment of immunogenicity for the development of Biosimilars.
Review in Bioanalysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immunogenicity knowledge and the analytical capabilities to characterize molecules have evolved within the last decade. This creates opportunities in Biosimilar development by applying new strategies to demonstrate similarity between a proposed Biosimilar to its Reference.Within Immunogenicity Risk Assessment for Biosimilars, in silico and in vitro immunogenicity assessment tools are being evaluated for their utility in Biosimilar development. An ISI including an Immunogenicity Risk Assessment is recommended for Biosimilars within the dossier of licensing applications to facilitate the review by Health Authorities and to explain the immunogenicity in conjunction with analytical and clinical data. Operational aspects should also be considered to refine immunogenicity testing of Biosimilars, e.g. S/N ratio and singlicate sample analysis.
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.