Table 1.

Data requirements for the approval of a biosimilar and a reference medicinal product. (Adapted from [1]).

Reference Medicinal Product	Biosimilar Medicinal Product
Risk Management Plan	Risk Management Plan
Clinical studies: -Safety and efficacy -PK/PD -Immunogenicity	Comparative clinical studies: -Safety and efficacy -PK/PD -Immunogenicity Non-clinical comparative studies
Non-clinical studies	Comparative non-clinical studies
Pharmaceutical quality studies	Comparative quality studies: Pharmaceutical quality studies, namely, full data requirements regarding pharmaceutical quality, as well as additional quality studies comparing the structure and biological activity of the biosimilar medicine with the reference medicine.