1. BioSim. Biosimilares: Nuevas Formas de Innovar. Position Paper. Coordinado por Gonzalo Calvo
https://www.biosim.es/documentos/Biosimilares%20position%20paper.pdf
2. Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32003L0063&from=ES
3. European Medicines Agency: Similar Biological Medicinal Products (Overarching Guideline). CHMP/437/04 Rev. 1
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf
4. European Medicines Agency: Similar Biological Medicinal Products Containing Biotechnology Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. EMEA/CHMP/BMWP/42832/2005 Rev. 1
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf
5. European Medicines Agency: Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. EMA/CHMP/BWP/247713/2012 Rev.1
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf