1. Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular weight pharmaceuticals;Crommelin;Eur. J. Hosp. Pharm. Sci.,2005
2. Characterizing biological products and assessing comparability following manufacturing changes;Chirino;Nat. Biotechnol.,2004
3. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004;European Parliament and Council;Official J. Eur. Union,2004
4. European Medicines Agency (2005) Guideline on similar biological medicinal products (http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf)
5. European Medicines Agency (2006) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues (http://www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf)