Biocreep refers to the cyclical phenomenon where a slightly inferior treatment becomes the active control for the next generation of NI trials which over time leads to degradation of the efficacy of the investigational treatment.1

“A product can be considered bioequivalent to the brand‐name drug if after administration of the same dose, it exhibits a similar degree and rate of absorption. These features guarantee the comparability of two drug preparations in terms of in vivo efficacy and safety and make them interchangeable and replaceable. Since efficacy studies are not necessary, some clinicians and patients have expressed concerns about the therapeutic equivalence of generic drugs. Nevertheless, evidence from multiple studies demonstrated the therapeutic equivalence between generics and brand‐name medications across multiple disease areas, even from real‐world evidence. This evidence invalidates the widespread theory of the clinical superiority of brand-name drugs compared to generic drugs in cardiovascular diseases. However, this does not mean that generics can automatically be considered bioequivalent each other.”1

Indeed, drug substitution can be critical in particular situations, such as the use of drugs with a narrow therapeutic index (NTI). Moreover, generics cannot automatically be considered bioequivalent with each other due to the biocreep phenomenon. In Italy, the regulatory authority has established the Transparency Lists which include the medications that will be automatically substituted for brand‐name drugs, except in exceptional cases. This is a useful tool to guide prescribers and guarantee pharmaceutical sustainability, but it does not consider the biocreep phenomenon.

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References

  1. D’Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues – the encounters of academic consultants in statistics. Stat Med. 2003;22:169–186

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