1. Kozlowski S, Woodcock J, Midthun K, Sherman RB. Developing the nation’s biosimilars program. N Engl J Med. 2011;365(5):385–8.
2. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London, UK. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf . Accessed 30 March 2016.
3. European Medicines Agency. Guideline on similar biological medicinal products. London, UK. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . Accessed 30 March 2016.
4. US Food and Drug Administration. Guidance for industry: biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Rockville, MD. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf . Accessed 30 March 2016.
5. US Food and Drug Administration. Guidance for industry: quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Rockville, MD. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf . Accessed 30 March 2016.