Module 9 2024

05/09/2024

Challenges as Treatments may have Moved on e.g. Oncology ⚫ New therapies may have been added to standard treatment regimens and may drown out the effect of the test medication ⚫ Exact effect of the test product in the new chemotherapy regimen will not be known. ⚫ Target population may decline or change as treatments become more and more personalized. ⚫ Thus even now it is becoming less and less feasible to conduct an appropriately designed equivalence trials in some indications ; in the future this will only get worse, ⚫ Yet unless biosimilars can be developed, treatment costs will continue to spiral unabated.

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Extrapolation Report

Review of all relevant literature

⚫ Same underlying pathology across indications?

⚫ MoA of drug in relation to pathology of disease

⚫ Is PK across indications similar?

⚫ Is PD across indications similar?

⚫ Review data supporting efficacy across indications.

⚫ Is test indication sensitive to detect differences in safety and immunogenicity for all approved indication?

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