Module 9 2021

22/03/2021

DEMONSTRATING INTERCHANGEABILITY?

How much data?

– Molecular complexity – Level of similarity – Knowledge of impact of differences – Known risks e.g. immune related reactions Interchangeability study – Switch study generally required (unless e.g. single administration) US Reference (12 mths):

US Ref. Biosimilar (4 x 3 mths) – Pimary Endpoint: AUC τ and C max (steady state after last switch ; ensure reference washed out); Margin 80 – 125% – Secondary Endpoint: PD, Immunogenicity, Safety, Efficacy. Biosimilar US Ref.

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DEMONSTRATING INTERCHANGEABILITY?

Post -marketing Safety Monitoring Considerations Take into consideration

– any particular safety or effectiveness concerns associated reference product or putative interchangeable product – the specific condition of use and patient population, and patient exposure in the interchangeability development program. ● Post marketing safety monitoring for an interchangeable product should also have adequate pharmacovigilance mechanisms in place.

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