Multidisciplinary: biosimilar

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

Overarching biosimilar guidelines

Guidelines

Product-specific biosimilar guidelines

Guidelines

Reflection papers

Other guidelines relevant for biosimilars

Guidelines