Highly purified charge variants of a proposed biosimilar to Omalizumab: impact on in vitro potency and stability under thermal stress

Author:

Gupta Tarun,Seshadri SriramORCID

Publisher

Springer Science and Business Media LLC

Subject

General Medicine,Bioengineering,Biotechnology

Reference17 articles.

1. Xiao Z, Yin X, Han L, Sun B, Shen Z, Liu W, Yu F (2018) Comprehensive approach for evaluating charge heterogeneity in biosimilars. Eur J Pharm Sci 115:19–24. https://doi.org/10.1016/j.ejps.2018.01.016

2. FDA Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product (2015). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product. Accessed Apr 2015

3. EMA Guideline on similar biological medicinal products (2014). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed Oct 2014

4. Yamaguchi T, Arato T (2011) Quality, safety and efficacy of follow-on biologics in Japan. Biologicals 39:328–332. https://doi.org/10.1016/j.biologicals.2011.06.015

5. Declerck P, Danesi R, Petersel D, Jacobs I (2017) The language of biosimilars: clarification, definitions, and regulatory aspects. Drugs 77:671–677. https://doi.org/10.1007/s40265-017-0717-1

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