1. European Medicines Agency. Guideline on similar biological medicinal products. October 23, 2014. CHMP/437/04 Rev 1. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed February 28, 2016.
2. U. S. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015. Available at: http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed February 28, 2016.
3. Use of biosimilars in inflammatory bowel disease: statements of the Italian Group for Inflammatory Bowel Disease;Annese;Dig Liver Dis,2014
4. Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics;Devlin;Can J Gastroenterol,2013
5. The challenge of indication extrapolation for infliximab biosimilars;Feagan;Biologicals,2014