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version 7 or above to view PDF A Discussion Guide for Health-System Pharmacists on Biosimilars activities to ensure the safe use of biosimilars. Frequently Asked Questions about Biologics and Biosimilars. Key Summary Points. 62.pdf. Published September 27, 2012. Accessed December 1, 2015. pdf. Accessed October 15, 2014. 22. US Food and Drug Administration. Background information: lists of licensed biological products with reference product Biosimilars become available after the patent on the originator biologic drug expires. There are no expected differences in efficacy and safety between a ty between a biosimilar and the biologic drug that was already authorized for sale”.2 alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-. The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development. pan-Canadian Oncology Biosimilars Initiative, funded by the pan-Canadian Available from: igbamedicines.org/doc/Module1.pdfA biosimilar is a new, highly similar version of a biologic drug that comes to the Canadian market after the patent for the original product has expired. under section 351(a) against which a biological product is evaluated.” ▫ Data from animal studies and certain clinical studies comparing a proposed biosimilar Information on Alberta's Biosimilar Initiative, the special authorization Coalition of Medicines Regulatory Authorities – Biosimilars Statement (PDF,. The Biosimilars Initiative is switching PharmaCare patients taking Remicade for biosimilar brand versions of infliximab (Inflectra®and Renflexis™).