围绕相似生物治疗药物技术标准的争议：获取与竞争的障碍？ - Suppr

Suppr

超能文献

The controversy around technical standards for similar biotherapeutics: barriers to access and competition?.

作者信息

González Claudia Patricia Vaca, Muñoz Carolina Gómez

出版信息

Pharmacoepidemiol Drug Saf. 2020 Nov;29(11):1518-1522. doi: 10.1002/pds.5100. Epub 2020 Sep 22.

DOI:10.1002/pds.5100

PMID:32964695

Abstract

摘要

相似文献

The controversy around technical standards for similar biotherapeutics: barriers to access and competition?.

Pharmacoepidemiol Drug Saf. 2020 Nov;29(11):1518-1522. doi: 10.1002/pds.5100. Epub 2020 Sep 22.

Comparing Onset of Biosimilar Versus Generic Competition in the United States.

Clin Pharmacol Ther. 2020 Dec;108(6):1308-1314. doi: 10.1002/cpt.1981. Epub 2020 Aug 17.

Current Japanese Regulatory Systems for Generics and Biosimilars.

J Pharm Sci. 2018 Mar;107(3):785-787. doi: 10.1016/j.xphs.2017.10.040. Epub 2017 Nov 4.

Frontiers in nonclinical drug development: biosimilars.

Vet Pathol. 2015 Mar;52(2):419-26. doi: 10.1177/0300985814547282. Epub 2014 Aug 26.

Biologic Drugs, Biosimilars, and Barriers to Entry.

Health Matrix Clevel. 2015;25:139-61.

Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012-2018.

Clin Pharmacol Ther. 2021 Feb;109(2):367-371. doi: 10.1002/cpt.1983. Epub 2020 Aug 7.

Strategic considerations under the Biologics Price Competition and Innovation Act.

Expert Opin Ther Pat. 2013 Aug;23(8):915-8. doi: 10.1517/13543776.2013.813935. Epub 2013 Jul 6.

On safety margin for drug interchangeability.

J Biopharm Stat. 2017;27(2):293-307. doi: 10.1080/10543406.2016.1265540. Epub 2016 Dec 2.

Health Aff (Millwood). 2015 Feb;34(2):294-301. doi: 10.1377/hlthaff.2014.0482.

BIOSIMILAR DRUGS ARE NOT GENERICS.

Endocr Pract. 2016 Jan;22(1):6-7. doi: 10.4158/EP151135.ED.

引用本文的文献

Global Harmonization of Biosimilar Development by Overcoming Existing Differences in Regional Regulatory Requirements - Outcomes of a Descriptive Review.

Ther Innov Regul Sci. 2025 Mar;59(2):245-255. doi: 10.1007/s43441-024-00740-4. Epub 2025 Jan 16.

Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.

BioDrugs. 2022 May;36(3):359-371. doi: 10.1007/s40259-022-00533-x. Epub 2022 May 21.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验

相似文献

The controversy around technical standards for similar biotherapeutics: barriers to access and competition?.

Pharmacoepidemiol Drug Saf. 2020 Nov;29(11):1518-1522. doi: 10.1002/pds.5100. Epub 2020 Sep 22.

Comparing Onset of Biosimilar Versus Generic Competition in the United States.

Clin Pharmacol Ther. 2020 Dec;108(6):1308-1314. doi: 10.1002/cpt.1981. Epub 2020 Aug 17.

Current Japanese Regulatory Systems for Generics and Biosimilars.

J Pharm Sci. 2018 Mar;107(3):785-787. doi: 10.1016/j.xphs.2017.10.040. Epub 2017 Nov 4.

Frontiers in nonclinical drug development: biosimilars.

Vet Pathol. 2015 Mar;52(2):419-26. doi: 10.1177/0300985814547282. Epub 2014 Aug 26.

Biologic Drugs, Biosimilars, and Barriers to Entry.

Health Matrix Clevel. 2015;25:139-61.

Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012-2018.

Clin Pharmacol Ther. 2021 Feb;109(2):367-371. doi: 10.1002/cpt.1983. Epub 2020 Aug 7.

Strategic considerations under the Biologics Price Competition and Innovation Act.

Expert Opin Ther Pat. 2013 Aug;23(8):915-8. doi: 10.1517/13543776.2013.813935. Epub 2013 Jul 6.

On safety margin for drug interchangeability.

J Biopharm Stat. 2017;27(2):293-307. doi: 10.1080/10543406.2016.1265540. Epub 2016 Dec 2.

Health Aff (Millwood). 2015 Feb;34(2):294-301. doi: 10.1377/hlthaff.2014.0482.

BIOSIMILAR DRUGS ARE NOT GENERICS.

Endocr Pract. 2016 Jan;22(1):6-7. doi: 10.4158/EP151135.ED.

引用本文的文献

Global Harmonization of Biosimilar Development by Overcoming Existing Differences in Regional Regulatory Requirements - Outcomes of a Descriptive Review.

Ther Innov Regul Sci. 2025 Mar;59(2):245-255. doi: 10.1007/s43441-024-00740-4. Epub 2025 Jan 16.

Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.

BioDrugs. 2022 May;36(3):359-371. doi: 10.1007/s40259-022-00533-x. Epub 2022 May 21.