Search results for analytics

Front-loading biosimilar development with analytical characterization

Abstract: An online roundtable discussion entitled ‘Front-loading biosimilar development with analytical characterization’ was hosted by BioPharmaSpec. The panellists discussed different regulatory approaches to the clinical trials needed for approval and how this can affect structural and functional characterization; the best way to ‘front-load’ characterization Submitted: 18 June 2022 Revised: 19 July 2022; Accepted: 20 July […]

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Supporting biosimilarity and extrapolation

Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies and analytics in establishing and confirming biosimilarity are discussed in this paper. Submitted: 28 July 2015; Revised: 15 August 2015; Accepted: 16 August 2015; Published […]

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