Marketing authorisation procedures for biosimilars follow the same CTD registration dossier format as other biologic product classes. An additional element for biosimilar applications is the assessment of similarity against the reference medicinal product, which is  presented separately as a distinct Biosimilarity Assessment Report in Module 3 of the CTD structure.

The Biosimilarity Assessment Report summarizes and critically presents the similarity exercise data in support of the overall biosimilarity claim, ranging from the applicable quality attributes of the target product profile up to potentially supporting non-clinical and clinical studies.

Biopharma Excellence can support with this central element of the biosimilar registration dossier in frame of your planned CTA/IND and MAA/BLA.