1. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Published December 18, 2014. Accessed 20 Oct 2021. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf.
2. US Food and Drug Administration. Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product. Published April 2015. Accessed 20 Oct 2021. https://www.fda.gov/media/82647/download.
3. European Medicines Agency. Biosimilars in the EU. Information guide for healthcare professionals. Accessed 20 Oct 2021. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.
4. US Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Published December 2016. Accessed 20 Oct 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-data-support-demonstration-biosimilarity-reference-product.
5. Wolff-Holz E, Tiitso K, Vleminckx C, Weise M. Evolution of the EU biosimilar framework: past and future. BioDrugs. 2019;33(6):621–34.