1. WHO (2016) Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). In: Standardization ECoB, editor. Expert Committee on Biological Standardization. Geneva: World Health Organization; 1–30.
2. Kirchhoff CF, Wang XM, Conlon HD, Anderson S, Ryan AM, Bose A. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114(12):2696–705. https://doi.org/10.1002/bit.26438.
3. EMA (2018) Guideline on non-clinical and clinical development of similar biolgic medicinal products containing recombinant erythropoietins. In: Use CfMPfH, editor. Product-specific biosimilar guidelines. London, UK: European Medicines Agency; 1–8.
4. FDA: Biologics Products & Establishments (2021) https://www.fda.gov/vaccines-blood-biologics/biologics-products-establishments. Accessed 4 Nov 2021.
5. FDA. Development of therapeutic protein Biosimilars: comparative analytical assessment and other quality-related considerations. Guidance for industry. Washington DC: Center for Biologics Evaluation and Research (CBER); 2019. p. 1–31.