Biosimilars and Bioanalytical Methods
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Scope of this subject
This cluster of papers focuses on the immunogenicity of biosimilar therapeutics, including the validation of bioanalytical methods for assessing immunogenicity, the impact of manufacturing changes on immunogenicity, and the clinical outcomes and safety of switching from reference biologics to biosimilars. The use of dried blood spots for bioanalysis and the regulatory considerations for biosimilars are also prominent topics within this cluster.
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Research vocabulary
biosimilars; anti-drug antibodies; biologic drugs; biosimilar approval; biosimilar switching; infliximab biosimilar; biosimilarity; CT-P13; adalimumab biosimilar; biological drugs; biosimilar development; ligand binding assay; antidrug antibodies; biosimilar interchangeability; biosimilar uptake; biosimilar insulin; biosimilarity assessment; biosimilar adoption; biosimilar regulation; biosimilar safety; biological medicines; reference products; biosimilar substitution; trastuzumab biosimilar; rituximab biosimilar
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Numeric address and provenance
Morton address: 36249302993643725 · morton4x16-v1
Coordinates: (1, 24, 2403, 12255). The address interleaves categorical identifier bits. Nearby addresses are not guaranteed to describe semantically similar subjects.
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