- Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, luglio 2015
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues, dicembre 2014
- Guideline on similar biological medicinal products (Ema, ottobre 2014)
- Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor, giugno 2006
- Similar medicinal products containing somatropin, giugno 2006
- Non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins, ottobre 2009
- Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues, settembre 2015
- Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues, dicembre 2012
- Similar biological medicinal products containing recombinant erythropoietins, dicembre 2012
- Similar biological medicinal products containing interferon beta, settembre 2013
- Similar biological medicinal products containing recombinant follicle-stimulating hormone, settembre 2013
- Reflection Paper - Non-clinical and clinical development of similar medicinal Products containing recombinant interferon alfa, aprile 2009
- Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues, novembre 2007
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products, giugno 2005
- Immunogenicity assessment of biotechnology-derived therapeutic proteins, novembre 2010
- Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, dicembre 2012