CLINICAL TRIAL;
DRUG EFFICACY;
DRUG QUALITY;
DRUG SAFETY;
EUROPEAN UNION;
HEALTH CARE POLICY;
HUMAN;
NOTE;
PATENT;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
BIOPHARMACEUTICS;
DRUG EVALUATION, PRECLINICAL;
DRUG RECALLS;
EUROPE;
EUROPEAN UNION;
HUMANS;
LEGISLATION, DRUG;
Anonymous. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. (EMEA, London, 2006; accessed 4 March 2008).
Anonymous. 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, London, 2006; accessed 4 March 2008).
Anonymous. 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 somatropin. (EMEA, London, 2006; accessed 4 March 2008). http://www.emea.europa.eu/pdfs/ human/biosimilar/9452805en.pdf
Anonymous. 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 human soluble insulin. (EMEA, London, 2006; accessed 4 March 2008).
Anonymous. 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 granulocyte-colony stimulating factor. (EMEA, London, 2006; accessed 4 March 2008).
http://www.patentdocs.org/2009/12/followon-biologics-news-briefs-no-10. html Similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues CHMP/42832/05 http://www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf Accessed 21 December 2009
Anonymous EMEA, London, 2006; accessed 3 March 2008
Anonymous. Questions and answers on recommendation for refusal of marketing application for alpheon. (EMEA, London, 2006; accessed 3 March 2008). 〈http://www.emea.europa.eu/pdfs/human/opinion/19089606en.pdf〉
Anonymous Insulin Human Long Marvel; Insulin Human 30/70 Mix Marvel. (EMEA, London; 2008; accessed 28 February 2008
Anonymous. Questions and answers on the withdrawal of the marketing authorisation application for Insulin Human Rapid Marvel; Insulin Human Long Marvel; Insulin Human 30/70 Mix Marvel. (EMEA, London; 2008; accessed 28 February 2008). 〈http://www.emea.europa.eu/humandocs/PDFs/EPAR/ insulinhumanrapidmarvel/419308en.pdf〉