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
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