期刊
DRUG DISCOVERY TODAY
卷 23, 期 3, 页码 616-625出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.drudis.2018.01.009
关键词
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资金
- MTA-PE Translational Glycomics Momentum (Lendulet) of the Hungarian Academy of Sciences [97101]
- National Research, Development and Innovation Office (NKFIH) of the Hungarian Government [K 116263]
- Horvath Csaba Laboratory of Bioseparation Sciences [BIONANO_GINOP-2.3.2-15-2016-00017, 136]
The recent expiration of several protein therapeutics opened the door for biosimilar development. Biosimilars are biologic medical products that are similar but not identical copies of already-authorized protein therapeutics. Critical quality attributes (CQA), such as post-translational modifications of recombinant biotherapeutics, are important for the clinical efficacy and safety of both the innovative biologics and their biosimilar counterparts. Here, we summarize biosimilarity CQAs, considering the regulatory guidelines and the statistical aspects (e.g., biosimilarity index) and then discuss glycosylation as one of the important attributes of biosimilarity. Finally, we introduced the 'Glycosimilarity Index', which is based on the averaged biosimilarity criterion.
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