1. Biologics Price Competition and Innovation Act (2009) [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf [Accessed 2012 May 31]
2. See section 505(b)(2) and 505(j) of the FD&C Act (21 U.S.C. 355(b)(2) and 355(j)) [online]. Available from URL: http://www.fda.gov [Accessed 2012 May 31]
3. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products. CHMP/437/04 [online]. Available from URL: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf [Accessed 2012 April 27]
4. Zuñiga L, Calvo B. Regulatory aspects of biosimilars in Europe. Trends Biotechnol 2009; 27: 385–7
5. Committee for Medicinal Products for Human Use (CHMP). Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. EMA/CHMP/BWP/617111/2010 [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/02/WC500102285.pdf [Accessed 2012 May 31]