Multidisciplinary: 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.
- Similar biological medicinal products - Scientific guideline
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Scientific guideline
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues - Scientific guideline
- 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 - Scientific guideline
- Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Scientific guideline
- Similar biological medicinal products containing interferon beta
- Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues - Scientific guideline
- Similar biological medicinal products containing recombinant erythropoietins - Scientific guideline
- Similar biological medicinal products containing recombinant follicle-stimulating hormone - Scientific guideline
- 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) - Scientific guideline
Reflection papers
- Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues - Scientific guideline
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - Scientific guideline
- Immunogenicity assessment of biotechnology-derived therapeutic proteins - Scientific guideline
- Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use - Scientific guideline
- Biosimilars - What are the key pharmacokinetic considerations in the assessment of biosimilarity?