Analytical strategies for assessing comparability of biosimilars
作者： Robert J. Falconer , Dianne Jackson-Matthews , Stephen M. Mahler
DOI: 10.1002/JCTB.2629
关键词:
摘要: Biosimilar products are required by regulatory authorities to have appropriate and comparable quality, safety efficacy with a reference biologic product. The analytical techniques that available manufacturers of biosimilar medicines well advanced present range options characterize the compare them relevant marketed This variety methods can be used investigate attributes candidate biologic, ensures orthogonal deployed single attribute, facilitating rigorous structural characterization physicochemical evaluation. These methodologies not only enable evidence for bio-comparability amassed but also developer biosimilars incorporate risk mitigation into development strategy. review discusses support comparability testing, handling material strategic aspects commercializing or follow-on biological medicinal products.
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