Multidisciplinary: biosimilar

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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


Reflection papers

Other guidelines relevant for biosimilars


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