Biosimilars – Regulatory Primer for Formulation Scientists

The EU regulatory pathway for marketing authorization of biosimilar medicinal products was established in 2005. This presentation will illustrate how the principles have been applied in practice to authorize different products, including implications for product formulation.

• EU regulatory framework for biosimilars
• Practical considerations for choice of Reference Product
• Case examples to illustrate multidisciplinary weight of evidence for authorization
• Considerations for justifying differences in drug product formulation