Spring Intro 2023

03/03/2023

Legal environment and its consequences

• Generic – Article 10.1 Reference product, Bio-equivalence study/BCS biowaiver , SmPC and PL • Bioequivalence study: Randomized, two-period, two-sequence, cross over study in healthy volunteers • Hybrid – Article 10.3 Reference product, comparative quality, in-vitro, in-vivo, PK, PD, efficacy and safety (Therapeutic equivalence study) • Therapeutic equivalence study: Randomized, double-blind, placebo and active controlled study

11 Understanding Clinical Development Program, March 2022

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Legal environment and its consequences

Well-established – Article 10a – Bibliographic applications • Data requirements as for a full original dossier – published literature does not have details • Bridging the product to the evidence from literature

12 Understanding Clinical Development Program, March 2022

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