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Article

Molecular Biosimilarity--A Paradigm Shift

2022-08-10

Abstract excerpt

Scientific, technical and bioinformatics advances have made it possible to establish analytics-based molecular biosimilarity for the approval of biosimilars. If the molecular structure and other product- and process-related attributes are comparable within the limits of testing then a biosimilar candidate would have safe safety and efficacy as its reference products. The current model of animal and human testing b...

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Literature Corpus work
b9918cde-71a1-5b91-be59-faa19d9c3df5
DOI
10.20944/preprints202208.0194.v1
Open publication

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Molecular Biosimilarity--A Paradigm ShiftDOI 10.20944/preprints202208.0194.v1
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