互换性、免疫原性与生物类似药。 - Suppr

Interchangeability, immunogenicity and biosimilars.

作者信息

Ebbers Hans C, Crow Stacy A, Vulto Arnold G, Schellekens Huub

机构信息

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.

出版信息

Nat Biotechnol. 2012 Dec;30(12):1186-90. doi: 10.1038/nbt.2438.

DOI:10.1038/nbt.2438

PMID:23222784

Abstract

摘要

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相似文献

Interchangeability, immunogenicity and biosimilars.

Nat Biotechnol. 2012 Dec;30(12):1186-90. doi: 10.1038/nbt.2438.

Actas Dermosifiliogr. 2015 Sep;106(7):545-9. doi: 10.1016/j.ad.2015.04.006. Epub 2015 May 16.

Actas Dermosifiliogr. 2015 Sep;106(7):550-4. doi: 10.1016/j.ad.2015.04.008. Epub 2015 Jun 3.

Are we ready to close the discussion on the interchangeability of biosimilars?

Drug Discov Today. 2019 Oct;24(10):1963-1967. doi: 10.1016/j.drudis.2019.06.016. Epub 2019 Jun 26.

Demystifying biosimilars: development, regulation and clinical use.

Future Oncol. 2019 Mar;15(7):777-790. doi: 10.2217/fon-2018-0680. Epub 2018 Nov 30.

Regul Toxicol Pharmacol. 2016 Apr;76:199-208. doi: 10.1016/j.yrtph.2015.12.013. Epub 2015 Dec 28.

The regulatory framework of biosimilars in the European Union.

Drug Discov Today. 2012 Jan;17(1-2):63-70. doi: 10.1016/j.drudis.2011.08.001. Epub 2011 Aug 12.

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Expert Rev Clin Pharmacol. 2015;8(5):649-59. doi: 10.1586/17512433.2015.1071188.

Farm Hosp. 2010 Mar;34 Suppl 1:16-8. doi: 10.1016/S1130-6343(10)70004-0.

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JAMA. 2024 Oct 15;332(15):1235-1236. doi: 10.1001/jama.2024.15225.

引用本文的文献

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Immunol Res. 2017 Feb;65(1):419-422. doi: 10.1007/s12026-016-8843-5.

Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies.

Front Pharmacol. 2016 Jun 29;7:193. doi: 10.3389/fphar.2016.00193. eCollection 2016.

Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications.

J Immunol Res. 2016;2016:1298473. doi: 10.1155/2016/1298473. Epub 2016 Jun 29.

本文引用的文献

The safety of switching between therapeutic proteins.

Expert Opin Biol Ther. 2012 Nov;12(11):1473-85. doi: 10.1517/14712598.2012.711308. Epub 2012 Jul 31.

Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study.

Clin Nephrol. 2012 Jan;77(1):8-17. doi: 10.5414/cn107304.

Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity.

Pharm Res. 2012 Jun;29(6):1454-67. doi: 10.1007/s11095-011-0621-4. Epub 2011 Nov 18.

Generic substitution: a need for clarification.

Br J Clin Pharmacol. 2011 Jun;71(6):966-7; author reply 968. doi: 10.1111/j.1365-2125.2010.03872.x.

Acceptable changes in quality attributes of glycosylated biopharmaceuticals.

Nat Biotechnol. 2011 Apr;29(4):310-2. doi: 10.1038/nbt.1839.

Kidney Int. 2011 Jul;80(1):88-92. doi: 10.1038/ki.2011.68. Epub 2011 Mar 23.

Eur J Haematol. 2011 Apr;86(4):277-88. doi: 10.1111/j.1600-0609.2010.01566.x. Epub 2011 Jan 25.

Dosing strategies for conversion of haemodialysis patients from short-acting erythropoiesis stimulating agents to once-monthly C.E.R.A.: experience from the MIRACEL study.

Int J Clin Pract. 2011 Jan;65(1):64-72. doi: 10.1111/j.1742-1241.2010.02551.x. Epub 2010 Nov 22.

Quality of original and biosimilar epoetin products.

Pharm Res. 2011 Feb;28(2):386-93. doi: 10.1007/s11095-010-0288-2. Epub 2010 Oct 1.

Generic and therapeutic substitutions in the UK: are they a good thing?

Br J Clin Pharmacol. 2010 Sep;70(3):335-41. doi: 10.1111/j.1365-2125.2010.03718.x.

Interchangeability, immunogenicity and biosimilars.

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Interchangeability, immunogenicity and biosimilars.

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