1. US Food and Drug Administration: guidance for industry: quality considerations in demonstrating biosimilarity to a reference protein product. Rockville, Md., Food and Drug Administration, 2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf . Accessed 15 Feb 2015
2. CHMP: guideline on similar biological medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf . Accessed 15 Feb 2015
3. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London: EMA, 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf . Accessed 15 Feb 2015
4. Rotenstein LS, Ran N, Shivers JP, Yarchoan M, Close KL (2012) Opportunities and Challenges for Biosimilars: what’s on the horizon in the global insulin market? Clin Diabetes 30:138–150
5. European Medicines Agency. Pending EC Decision. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002835/smops/Positive/human_smop_000706.jsp&mid=WC0b01ac058001d127 . Accessed 15 Feb 2015