1. Code of Federal Regulations . (as amended). Title 21, Part 320.1. Bioavailability and bioequivalence requirements .
2. European Commission . ( 2001 ). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use; Article 10(4) .
3. European Commission . ( 2006 ). European Commission press release (IP/06/511). Biotech medicines: First biosimilar drug on EU market. Brussels, 20 April 2006 .
4. European Medicines Agency . ( 2005 ). Guideline on Similar Biological Medicinal Products (CHMP/437/04). EMEA, London, 30 October .
5. European Medicines Agency . ( 2006a ). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues guidance on similar medicinal products containing recombinant erythropoietins. (EMEA/CHMP/BMWP/94526/2005 Corr.). EMEA, London, 22 March .