• Farmaci e biosimilari: la rivoluzione dei biotech:dalle eritropoietine agli anticorpi monoclonali in oncologia.
AIOM – Associazione Italiana di Oncologia Medica 2013
• Guidelines on evaluation of similar biotherapeutic products (WHO, 2010)
• Biosimilars: science, status and strategic perspective (2009). Kresse GB, Eur J Pharm & Biopharm
• The European Medicines Agency: Guidelines about biosimilars
http://www.ema.europa.eu
• The International Alliance of Patient Organisations: information on biosimilars for patients
http://www.patientsorganizations.org/biosimilars
• The National Comprehensive Cancer Network: information about biosimilars on
http://www.nccn.org/JNCCN/supplements/PDF/2011_Vol9_ Suppl_4_Biosimilars.pdf
• World Health Organisation: information about biosimilars on
http://www.who.int/medicines/services/inn/inn_bio/en/
• EMA Guidelines:
www.ema.europa.eu/ema
• Food and Drug Administration (FDA) Draft Guidance:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm290967.htm
