Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study
Author:
Affiliation:
1. Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi, India
Publisher
Informa UK Limited
Subject
Immunology,Immunology and Allergy
Link
https://www.tandfonline.com/doi/pdf/10.1080/19420862.2017.1402996
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3. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014 (http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf)
4. Assessing analytical comparability of biosimilars: GCSF as a case study
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