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| Discussion on the Quality Similarity Assessment of Bevacizumab Biosimilar |
ZHOU Li-ting( ),HU Ying-ying,XU Long-chang,LI Yi-jun,SAI Wen-bo,BAI Yu() |
| Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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Abstract Bevacizumab is one of the most popular subjects for the research and development of biosimilars. Based on the research data of 23 biosimilar sponsors and those of the original manufacturer, combined with the current domestic and international biosimilar guidelines as well as related literatures, the technical assessment key points of the quality similarity of bevacizumab biosimilar were discussed, including the general principles of similarity evaluation of biosimilars, identification of key quality attributes and similarity evaluation of bevacizumab.
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Received: 19 July 2020
Published: 11 December 2020
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Corresponding Authors:
Li-ting ZHOU,Yu BAI
E-mail: zhoult@cde.org.cn;baiy@cde.org.cn
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| [1] |
罗建辉, 韦薇, 项金忠, 等. 关于生物类似药研发与评价的思考. 中国药学杂志, 2015,50(6):473-476.
|
|
|
| [1] |
Luo J H, Wei W, Xiang J Z, et al. Comments and suggestions on development and evaluation of biosimilars. Chin Pharm J, 2015,50(6):473-476.
|
|
|
| [2] |
EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. 2014.[2020-06-27]. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf.
|
|
|
| [3] |
CFDA. 生物类似药研发与评价技术指导原则(试行). 2015.[2020-06-27]. http://www.cde.org.cn/zdyz.do?method=largePage&id=243.
|
|
|
| [3] |
CFDA, Guidelines for the development and evaluation of biosimilars (trial).2015.[2020-06-27]. http://www.cde.org.cn/zdyz.do?method=largePage&id=243.
|
|
|
| [4] |
EMA. Guideline on similar biological medicinal products. 2015.[2020-06-27]. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf.
|
|
|
| [5] |
FDA. Draft guidance for industry: development of therapeutic protein biosimilar: comparative analytical assessment and other quility considerations. 2019. [2020-6-27]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality.
|
|
|
| [6] |
FDA. Draft guidance for industry: development of therapeutic protein biosimilar: comparative analytical assessment and other quility considerations. 2017.[2020-6-27]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-withdraws-draft-guidance-industry-statistical-approaches-evaluate-analytical-similarity.
|
|
|
| [7] |
WHO. WHO Questions and Answers: similar biotherapeutic products.2018.[2020-6-27]. https://www.who.int/biologicals/expert_committee/QA_for_SBPs_ECBS_2018.pdf?ua=1.
|
|
|
| [8] |
周明, 宋媛媛, 陈晓媛, 等. 贝伐珠单抗注射液生物类似药临床研究设计及审评的考虑. 中国临床药理学杂志, 2019,35(18):2188-2192.
|
|
|
| [8] |
Zhou M, Song Y Y, Chen X Y, et al. Considerations of clinial trial design and medical review assessment about bevacizumab biosimilar. Chin J Clin Pharmacol, 2019,35(18):2188-2192.
|
|
|
| [9] |
Melosky B, Reardon D A, Nixon A B, et al. Bevacizumab biosimilars: scientific justification for extrapolation of indications. Future Oncol, 2018,14(24):2507-2520.
doi: 10.2217/fon-2018-0051
pmid: 29690784
|
|
|
| [10] |
FDA. MVASI. Washington: FDA, 2017.[2020-6-27]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761028Orig1s000ChemR.pdf.
|
|
|
| [11] |
FDA. ZIRABEV. Washington: FDA, 2019.[2020-6-27]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761099Orig1s000ChemR.pdf.
|
|
|
| [12] |
Seo N, Polozova A, Zhang M J, et al. Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab. Mabs, 2018,10(4):678-691.
doi: 10.1080/19420862.2018.1452580
pmid: 29553864
|
|
|
| [13] |
Yu C F, Zhang F, Xu G L, et al. Analytical similarity of a Proposed Biosimilar BVZ-BC to Bevacizumab. Analytical Chemistry, 2020,92(4):3161-3170.
doi: 10.1021/acs.analchem.9b04871
pmid: 31983199
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