1. European Commission (2013) Lo que debe saber sobre los medicamentos biosimilares. European Commission, Brussels Disponible en: http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations
2. European Medicines Agency (2014) EMA/940451/2011: EMA Procedural advice for users of the Centralised Procedure for Similar Biological Medicinal Products applications. European Medicines Agency, London Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166 . pdf
3. EMEA/CPMP/ICH/5721/03. ICH Topic Q 5 E. Comparability of Biotechnological/Biological Products. Step 5. Note for guidance on biotechnological/biological products subject to changes in their manufacturing process. (CPMP adopted June 2005). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002805.pdf
4. CHMP/437/04 Guideline on Similar Biological Medicinal Products. Disponible en: http://www.emea.eu.int/pdfs/human/biosimilar/043704en.pdf
5. Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios. Boletín Oficial del Estado, n° 178, (27 de julio de 2006)