Multidisciplinary: biosimilar

The European Medicines Agency's (EMA) 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 Microsoft Office document iconform for submission of comments on scientific guidelines .

Overarching biosimilar guidelines


Product-specific biosimilar guidelines


Reflection papers

Other guidelines relevant for biosimilars


How useful was this page?

Add your rating