Reports

Ethics of Clinical Trials to Evaluate Biosimilars

Biosimilars require extensive, expensive, and time-consuming human testing prior to market entry, a process vastly different than generics. So why are we still doing them?

Authors

Originally published on 03/09/2021 in MedRx IV

Ethical and human subject burdens of trials conducted to evaluate biosimilars

While generic drug entry has accomplished its intended goal in large measure, biosimilar entry has not been nearly as effective. Today, 8 in 10 small-molecule drugs are generics and prices of innovator drugs fall 85-95% upon entry of multiple generic competitors.

For biosimilars, the development of a single large-molecule drug typically spans 7 to 8 years and costs between $100 to $200 million. But there are potentially other costs incurred by testing biosimilars that have not been well explored.

This report approximates costs incurred by running trials of biosimilars and to the human subject volunteers. Coupled with the fact that biosimilar trials are not designed to produce new scientific or clinical insights, such trials fall short of the ethical standards of clinical research. The unnecessary and substantial costs imposed by biosimilar trial requirements is a source of potential value for Production Plus Profit Pricing (P-quad).

View the report here.

If biosimilar trials are not designed to produce new scientific or clinical insights, then in our view these trials fall short of the ethical standards of clinical research.
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