1. 1. European Medicines Agency. Biosimilars in the EU, Information guide for healthcare professionals. 2017. Available at: http://ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf. Accessed February 5, 2019).
2. 2. U.S. Food & Drug Administration (FDA) - Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. April 2015. Available at: https://www.fda.gov/media/135612/download. Accessed February 5, 2019).
3. 3. Blauvelt A, Cohen AD, Puig L, Vender R, van der Walt J, Wu JJ. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol. 2016;174(2):282-6.
https://doi.org/10.1111/bjd.14267
4. 4. Gupta SK, Chaudari PS, Nath R. Opportunities and challenges in biosimilar development. BioProcess International 2017. Available at: https://bioprocessintl.com/manufacturing/biosimilars/opportunitieschallenges-biosimilar-development/. Accessed February 5, 2019).
5. 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.
https://doi.org/10.1007/s40259-019-00377-y