Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

Author:

Webster Christopher J.,George Kelly L.,Woollett Gillian R.ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference55 articles.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process: Q5E. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guide line.pdf. Accessed 21 Jan 2021.

2. European Medicines Agency. Guideline on Similar Biological Medicinal Products, CHMP/437/04 Rev 1. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed 21 Jan 2021.

3. US Food and Drug Administration. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: Guidance for Industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf. Accessed 21 Jan 2021.

4. Declerck P, Mourad FR, Rudd PM. Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res. 2016;33:261–8. https://doi.org/10.1007/s11095-015-1790-3. Accessed 7 February 2021.

5. Jefferis R. Biologics: structural heterogeneity and immunogenicity. Br Jo Hosp Medi. 2017. https://doi.org/10.12968/hmed.2017.78.8.443. Accessed 7 February 2021.

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