The European Medicines Agency’s scientific guidelines on biosimilar medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Overarching biosimilar guidelines
- Product-specific biosimilar guidelines
- Other guidelines relevant for biosimilars
How useful is this page?
Average rating:Based on 25 ratings
Add your rating:
- See all ratings
0 ratings0 ratings1 ratings1 ratings23 ratings