行业分析 |
|
|
|
|
贝伐珠单抗生物类似药质量相似性评价探讨* |
周莉婷(),胡莹莹,徐隆昌,李怡君,赛文博,白玉() |
国家药品监督管理局药品审评中心 北京 100022 |
|
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 |
引用本文:
周莉婷,胡莹莹,徐隆昌,李怡君,赛文博,白玉. 贝伐珠单抗生物类似药质量相似性评价探讨*[J]. 中国生物工程杂志, 2020, 40(11): 102-109.
ZHOU Li-ting,HU Ying-ying,XU Long-chang,LI Yi-jun,SAI Wen-bo,BAI Yu. Discussion on the Quality Similarity Assessment of Bevacizumab Biosimilar. China Biotechnology, 2020, 40(11): 102-109.
链接本文:
https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.2007024
或
https://manu60.magtech.com.cn/biotech/CN/Y2020/V40/I11/102
|
[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.
|
|
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.
|
|
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 Draft guidance for industry: development of therapeutic protein biosimilar: comparative analytical assessment and other quility considerations. 2019.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 Draft guidance for industry: development of therapeutic protein biosimilar: comparative analytical assessment and other quility considerations. 2017.[2020-6-27].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.
|
|
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
|
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
|
Shared |
|
|
|
|
|
Discussed |
|
|
|
|