Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

European Journal of Pharmaceutical Sciences(2020)

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摘要
•Biosimilarity assessments of quality attributes (QAs) have been published in peer reviewed scientific publications for about 60% of approved biosimilars.•Dynamics of publications and reporting QA types increased over time in parallel with increased number of licensed biosimilars and appears to be affected by development of regulatory guidelines in 2012-2015.•Availability of a complete, publicly accessible (open access) and unbiased biosimilarity assessment of QAs might contribute to increased confidence and acceptance of biosimilars in clinical practice.
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关键词
Recombinant therapeutic protein,Biosimilar,Biosimilarity assessment,Analytical comparison,Quality attribute
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