Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab

mAbs5.30
Volume: 11, Issue: 1, Pages: 129 - 144
Published: Oct 19, 2018
Abstract
Biosimilars are biologic products that are highly similar to a licensed reference product in terms of quality, safety, and efficacy. SB5 is a biosimilar of Humira® (adalimumab) developed by Samsung Bioepis. To demonstrate its biosimilarity in quality to Humira®, we performed a comprehensive characterization in terms of structure, physicochemical properties, and biological properties following the International Conference on Harmonization, US...
Paper Details
Title
Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab
Published Date
Oct 19, 2018
Journal
Volume
11
Issue
1
Pages
129 - 144
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