Demonstrating Virtual Bioequivalence (VBE) using the Simcyp Simulator

Demonstrating Virtual Bioequivalence (VBE) using the Simcyp Simulator

Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. As a result, some branded drugs remain on the market well past the originator’s patent expiration, without cost-effective generic alternatives that could benefit patients. Model-informed drug development (MIDD), specifically physiologically-based pharmacokinetics (PBPK) leveraging in vitro data, is a proven, cost-effective option to consider in lieu of running an in vivo comparative clinical BE endpoint study.

The Landscape for Complex Generics

While there has been significant increase in generic drug approvals, two areas are lagging: ‘first generics’ and ‘complex generics’. FDA defines ‘first generics’ as the first approval for a manufacturer to market a generic drug product in the US. Figure 1 shows the rapid increase in generic approvals via the Abbreviated New Drug Application (ANDA) process, but also highlights that first generics account for less than 10% of the total. This is the case even though there are important market incentives— the first generic drug to make it to market after drug patent expiration enjoys a significant market share advantage, up to 90% over later arrivals.

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