Biosimilars in 3D: definition, development and differentiation.
作者信息
Abraham Ivo, Sun Diana, Bagalagel Alaa, Altyar Ahmed, Mohammed Abdulaziz, Tharmarajah Soba, MacDonald Karen
机构信息
Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA.
出版信息
Bioengineered. 2013 Jul-Aug;4(4):203-6. doi: 10.4161/bioe.25067. Epub 2013 May 16.
Abstract
摘要
相似文献
1
Biosimilars in 3D: definition, development and differentiation.三维视角下的生物类似药：定义、研发与差异化
Bioengineered. 2013 Jul-Aug;4(4):203-6. doi: 10.4161/bioe.25067. Epub 2013 May 16.
2
Frontiers in nonclinical drug development: biosimilars.非临床药物研发前沿：生物类似药
Vet Pathol. 2015 Mar;52(2):419-26. doi: 10.1177/0300985814547282. Epub 2014 Aug 26.
3
Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction.生物制剂（包括生物类似药）的安全性：现状与未来方向的视角。
Drug Saf. 2018 Nov;41(11):1013-1022. doi: 10.1007/s40264-018-0684-9.
4
A GUIDE TO FOLLOW-ON BIOLOGICS AND BIOSIMILARS WITH A FOCUS ON INSULIN.《后续生物制品和生物类似药指南：重点关注胰岛素》
Endocr Pract. 2018 Feb;24(2):195-204. doi: 10.4158/EP161728.RA.
5
The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference.生物制品和生物类似药在美国日益重要的作用：来自美国药师协会生物制品和生物类似药利益相关者会议的观点
J Am Pharm Assoc (2003). 2017 Sep-Oct;57(5):e15-e27. doi: 10.1016/j.japh.2017.05.014. Epub 2017 Jul 6.
6
Biosimilars: The US Regulatory Framework.生物类似药：美国监管框架。
Annu Rev Med. 2017 Jan 14;68:243-254. doi: 10.1146/annurev-med-051215-031022. Epub 2016 Oct 28.
7
Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.改善欧盟、美国和日本的肿瘤生物类似药上市情况：不良反应南方网络的最新政策回顾。
Lancet Oncol. 2020 Dec;21(12):e575-e588. doi: 10.1016/S1470-2045(20)30485-X.
8
Update on Biosimilars in Asia.亚洲生物类似药的最新进展。
Curr Rheumatol Rep. 2017 Aug;19(8):47. doi: 10.1007/s11926-017-0677-1.
9
Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.用于表征生物制药的分析工具及其对生物类似药的影响。
Nat Rev Drug Discov. 2012 Jun 29;11(7):527-40. doi: 10.1038/nrd3746.
10
Bioanalytical challenges of biosimilars.生物类似药的生物分析挑战。
Bioanalysis. 2014 Feb;6(3):349-56. doi: 10.4155/bio.13.307.
引用本文的文献
1
Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability.赋形剂提取和缓冲液交换对重组单克隆抗体稳定性的影响。
Mol Pharm. 2024 Apr 1;21(4):1872-1883. doi: 10.1021/acs.molpharmaceut.3c01157. Epub 2024 Feb 29.
2
Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product.生物类似药候选药物 ABP 654 与乌司奴单抗参比制剂的分析和功能相似性。
Drugs R D. 2023 Dec;23(4):421-438. doi: 10.1007/s40268-023-00441-7. Epub 2023 Oct 13.
3
Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria.罕见病中的生物类似药：以阵发性睡眠性血红蛋白尿为例。
Haematologica. 2023 May 1;108(5):1232-1243. doi: 10.3324/haematol.2022.281562.
4
Budget Impact Analysis of Switching to Rituximab's Biosimilar in Rheumatology and Cancer in 13 Countries Within the Middle East and North Africa.中东和北非13个国家中，在风湿病学和癌症领域改用利妥昔单抗生物类似药的预算影响分析。
Clinicoecon Outcomes Res. 2020 Sep 15;12:527-534. doi: 10.2147/CEOR.S265041. eCollection 2020.
5
A Framework for Integrating Biosimilars Into the Didactic Core Requirements of a Doctor of Pharmacy Curriculum.将生物类似药纳入药学博士课程教学核心要求的框架
Am J Pharm Educ. 2017 Apr;81(3):57. doi: 10.5688/ajpe81357.
6
Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.建立生物类似药的全面证据：监管考量及增强医疗界的信心
BioDrugs. 2017 Jun;31(3):175-187. doi: 10.1007/s40259-017-0218-5.
7
State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists.治疗肾性贫血的前沿生物类似物促红细胞生成素：欧洲经验及对美国肾病学家的启示
Int Urol Nephrol. 2015 Sep;47(9):1529-39. doi: 10.1007/s11255-015-1042-9. Epub 2015 Jul 30.
8
Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility.促红细胞生成素ζ在慢性肾脏病相关性贫血管理中的差异药理学及临床应用
Biologics. 2014 Apr 16;8:155-67. doi: 10.2147/BTT.S27578. eCollection 2014.
本文引用的文献
1
Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors.生物类似重组人粒细胞集落刺激因子的临床安全性。
Expert Opin Drug Saf. 2013 Mar;12(2):235-46. doi: 10.1517/14740338.2013.770472. Epub 2013 Feb 18.
2
Clinical safety of biosimilar recombinant human erythropoietins.生物类似重组人红细胞生成素的临床安全性。
Expert Opin Drug Saf. 2012 Sep;11(5):819-40. doi: 10.1517/14740338.2012.712681. Epub 2012 Aug 13.
3
Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry.质谱法对生物类似药、生物改良药和下一代抗体的表征。
Anal Chem. 2012 Jun 5;84(11):4637-46. doi: 10.1021/ac3002885. Epub 2012 May 14.
4
Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation.促红细胞生成素和非格司亭生物类似药的关键概念与关键问题。来自意大利血液学会、意大利实验血液学会和意大利骨髓移植小组的立场文件。
Haematologica. 2011 Jul;96(7):937-42. doi: 10.3324/haematol.2011.041210.
5
A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study.一项关于生物仿制药依泊汀阿尔法治疗血液透析患者肾性贫血的多层次决定因素、预测因素和临床结局的药物流行病学研究：MONITOR-CKD5 研究的背景和方法。
Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.
6
Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments.监测-GCSF 研究中生物类似物非格司亭降低癌症患者化疗引起的发热性中性粒细胞减少症发生率的更新：方案修正案。
Crit Rev Oncol Hematol. 2011 Mar;77(3):198-200. doi: 10.1016/j.critrevonc.2011.01.006.
7
Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim.MONITOR-GCSF 的背景和方法学：生物类似物粒细胞集落刺激因子非格司亭预防发热性中性粒细胞减少症的多层次决定因素、预测因素和临床结局的药物流行病学研究。
Crit Rev Oncol Hematol. 2011 Mar;77(3):184-97. doi: 10.1016/j.critrevonc.2010.01.014. Epub 2010 Mar 1.
8
Biosimilar therapeutics-what do we need to consider?生物类似药疗法——我们需要考虑什么？
NDT Plus. 2009 Jan;2(Suppl_1):i27-i36. doi: 10.1093/ndtplus/sfn177.
9
The challenge of biosimilars.生物类似药的挑战。
Ann Oncol. 2008 Mar;19(3):411-9. doi: 10.1093/annonc/mdm345. Epub 2007 Sep 14.
10
Biosimilars: how similar or dissimilar are they?生物类似药：它们有多相似或多不同？
Nephrology (Carlton). 2006 Aug;11(4):341-6. doi: 10.1111/j.1440-1797.2006.00594.x.
Zotero 插件