An Integrated Approach for a Structural and Functional Evaluation of Biosimilars: Implications for Erythropoietin-Reference-Cited by-同舟云学术

An Integrated Approach for a Structural and Functional Evaluation of Biosimilars: Implications for Erythropoietin

Published:2015-08 Issue:4 Volume:29 Page:285-300
ISSN:1173-8804
Container-title:BioDrugs
language:en
Short-container-title:BioDrugs

Author:

Gianoncelli Alessandra,Bonini Sara A.,Bertuzzi Michela,Guarienti Michela,Vezzoli Sara,Kumar Rajesh,Delbarba Andrea,Mastinu Andrea,Sigala Sandra,Spano Pierfranco,Pani Luca,Pecorelli Sergio,Memo Maurizio

Funder

Agenzia Italiana del Farmaco

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Link

http://link.springer.com/article/10.1007/s40259-015-0136-3/fulltext.html

Reference46 articles.

1. Epstain MS, Ehrenpreis ED, Kulkarni PM, FDA–Related Matters Committee of the American College of Gastroenterology. Biosimilars: the need, the challenge, the future: the FDA perspective. Am J Gastroenterol. 2014;109:1856–9.

2. European Medicines Agency. Biological medicinal products. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Brochure/2011/03/WC500104227.pdf . Accessed 26 May 2015.

3. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . Accessed 26 May 2015.

4. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). EMA/CHMP/BWP/247713/2012. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf . Accessed 26 May 2015.

5. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005 Rev1. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf . Accessed 26 May 2015.

Cited by 33 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Cancer treatment with biosimilar drugs: A review;Cancer Innovation;2024-04

2. Enhancing salt stress tolerance in kidney beans: The synergistic effects of biochar and salicylic acid in arid and semi-arid regions;Plant Stress;2024-03

3. Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering;Pharmaceutics;2023-08-04

4. Development and qualification of a high-yield recombinant human Erythropoietin biosimilar;2023-01-22

5. A Cost-effective Purification Process for Erythropoietin Biosimilar through Downstream Process Engineering;2023-01-18