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2. World Health Organization (WHO). Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009; https://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1, Accessed: 25 May 2020.
3. U.S. Food and Drug Administration (FDA). Biologic product definitions. https://www.fda.gov/media/108557/download Accessed: 29 Jan 2021.
4. Bundesgesetz über Arzneimittel und Medizinprodukte (Heilmittelgesetz, H., vom 15. Dezember 2000, Stand 1. August 2020, SR 812.21, Art. 4 Abs. 1 Bst. a novies.; https://www.fedlex.admin.ch/eli/cc/2001/422/de Accessed 29 Jan 2021.
5. Windisch J. Biosimilars versus original biologics. Similarities and differences from development to approval. Z Rheumatol. 2015;74(8):672–81.