CRED ERP 25

Figure 4. Comparison of data requirements for approval of a biosimilar versus the reference medicine

Risk management plan

Risk management plan

Comparative clinical studies  Safety and efficacy  PK/PD  Immunogenicity

Clinical studies  Safety and efficacy  PK/PD  Immunogenicity

Comparative non-clinical studies

Comparative quality studies

Non-clinical studies

Pharmaceutical quality studies

Pharmaceutical quality studies

Reference medicine Biosimilar medicine

The non-clinical and clinical data needed to approve a biosimilar are different from those needed for a biological medicine with a new active substance. This is because, by demonstrating biosimilarity, the biosimilar relies on the safety and efficacy experience gained with the reference medicine.

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