Biosimilars

Author:

Knezevic Ivana,Sheets Rebecca

Publisher

Elsevier

Reference28 articles.

1. Evaluation of similar biotherapeutic products (SBPs): scientific principles and their implementation;Knezevic;Biologicals,2011

2. Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy;Resolution WHA67.21,2014

3. WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products;Knezevic;Ann. N. Y. Acad. Sci.,2017

4. WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea, 24–26 August, 2010;Wadhwa;Biologicals,2011

5. On behalf of the participants of the WHO implementation workshop of regulatory expectations and assessment of biotherapeutics in Africa region. Meeting report;Rodgers,2015

Cited by 3 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. Biosimilars: Review of regulatory, manufacturing, analytical aspects and beyond;Microchemical Journal;2021-06

2. Biosimilars Regulation in the United States and FDA Approved Biosimilars from 2015-2018;Applied Clinical Research, Clinical Trials and Regulatory Affairs;2020-03-03

3. Regulation and Challenges of Biosimilars in European Union;Applied Clinical Research, Clinical Trials and Regulatory Affairs;2019-11-13

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