Module 18 2021

07/02/2021

Two important principles with generics / biosimilars…

 The reference product does not have to be approved in the MSs that are the subject of the application ● The single market principle applies  If the MA for the reference product is WITHDRAWN after approval of the generic… ● The generic licence does not have to be withdrawn

The Organisation for Professionals in Regulatory Affairs

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Article 10 applications

 10 (2) (b) ● GENERIC APPLICATION ● WHEN IS A PRODUCT A GENERIC? – SAME qualitative and quantitative COMPOSITION as the reference product – SAME pharmaceutical form – BIOEQUIVALENCE with the reference product – Demonstrated using bioavailability studies ● Different sales, esters, isomers, mixtures of isomers, derivatives – ARE CONSIDERED TO BE THE SAME DRUG SUBSTANCE – Unless their properties are different with respect to SAFETY and /or EFFICACY

The Organisation for Professionals in Regulatory Affairs

14

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