1. The FDA's assessment of follow-on protein products: a historical perspective;Woodcock;Nat. Rev. Drug Discov.,2007
2. Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology, United States Regulatory Agencies Unified Biotechnology website [online], (http://usbiotechreg.nbii.gov/Coordinated_Framework_1986_Federal_Register.html) (26 June 1986)
3. Biogenerics: the hope and the hype;Miller;Trends Biotechnol.,2009
4. Committee for Medical Products for Human Use. Guideline on Similar Biological Medicinal Products. CHMP/437/04 (CHMP adopted September 2005)
5. Committee for Medical Products for Human Use. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. EMEA/CHMP/BWP/49348/05 (CHMP adopted February 2006)