Les produits biologiques: aperçu

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Ezzell C. Magic bullets fly again. Scientific American 2001;280(4):34–41.

Nyarko K.A. Regulatory approach for subsequent entry biologics in Canada. Health Canada. Presented at the PMDA 3rd International Symposium on Biologics, Feb. 17, 2009, Tokyo, Japan. Texte publié sur le site www.pmda.go.jp/2009bio-sympo/file/IV-2_Nyarko_(Health%20Canada).pdf (consulté le 4 août 2009).

Shacter E. Quantification and significance of protein oxidation in biological samples. Drug Metab Rev 2000;32(3–4):307–26.

Robinson N. Protein deamidation. Proc Natl Acad Sci 2002;99:5283–8.

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Ross C Clemmesen K Svenson M Immunogenicity of interferon-beta in multiple sclerosis patients: influence of preparations, dosage, dose frequency and route of administration. Ann Neurol 2000;48:706–12.

Schellekens H. Biosimilar therapeutics — what do we need to consider? NDT Plus 2009;2[Suppl 1]:i27–i36.

European Medicines Agency. Evaluation of medicines for human use: refusal assessment report for Alpheon. Texte publié sur le site www.emea.europa.eu/humandocs/PDFs/EPAR/alpheon/H-585-RAR-en.pdf (consulté le 4 août 2009).

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McMahon E Reguly T. Canada: biosimilars in Canada: new draft guidelines from Health Canada. Texte publié sur le site www.mondaq.com/article.asp?articleid=83460 (consulté le 4 août 2009).

Organisation mondiale de la santé. WHO informal consultation on international nonproprietary names (INN) policy for biosimilar products. Geneva: World Health Organization; 2006. Texte publié sur le site www.who.int/medicines/services/inn/inn_bio/en/index.html (consulté le 3 juin 2009).