Multidisciplinary guidelines: biosimilar

The European Medicines Agency's scientific guidelines on biosimilar medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Tailored clinical approach for biosimilars

• Reflection paper on a tailored clinical approach in biosimilar development

Overarching biosimilar guidelines

• Similar biological medicinal products
• Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
• Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

Product-specific biosimilar guidelines

• Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues)
• Non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins
• Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
• Similar biological medicinal products containing interferon beta
• Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues
• Similar biological medicinal products containing recombinant erythropoietins
• Similar biological medicinal products containing recombinant follicle-stimulating hormone
• Similar medicinal products containing somatropin (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues)
• Non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha

Other guidelines relevant for biosimilars

• Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues
• ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products
• Immunogenicity assessment of biotechnology-derived therapeutic proteins
• Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use
• Biosimilars - What are the key pharmacokinetic considerations in the assessment of biosimilarity?