Table 2.

EMA’s regulatory guidelines related to the development and approval of biosimilars.

Topic	Title	Application
Overarching	- Guideline on similar biological medicinal products	General—applies to all biosimilars
Quality	- Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
Nonclinical and clinical	- Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Annexes	- Recombinant human erythropoietin - Recombinant GCSF - Recombinant human insulin - Recombinant human GH - INF-α and INF-β - Low-molecular-weight heparins - Monoclonal antibodies - Recombinant follicle-stimulating hormone	Specific—product data requirements

GCSF, granulocyte colony-stimulating factor; GH, growth hormone; INF-α, interferon alpha; INF-β, interferon beta.