1. The FDA’s assessment of follow-on protein products: A historical perspective;Woodcock;Nature Reviews: Drug Discovery,2007
2. Biogenerics: The hope and the hype;Miller;Trends in Biotechnology,2009
3. Committee for Medical Products for Human Use (2005) Guideline on Similar Biological Medicinal Products. CHMP/437/04 (CHMP adopted September).
4. Committee for Medical Products for Human Use (2006) Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. EMEA/CHMP/BWP/49348/05 (CHMP adopted February).
5. Committee for Medical Products for Human Use (2006) Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. EMEA/CHMP/42832/05 (CHMP adopted February).