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The Emerging Market Dynamics Of Targeted Therapeutics
Calfee and DuPre look at the market for targeted therapeutic drugs and speculate on how the absence of a clear path for biogenerics may affect competition, pricing and research prospects for these powerful medicines.
We cannot provide a concrete forecast of biotech drug prices, but certain trends are likely to be important. We can expect the rapid accretion of what might be called QALY-driven drugs: drugs that provide large benefits, especially for previously poorly treated conditions, but at high prices and, often, significant total expenditures. This does not rule out, however, a new generation of old-style blockbuster drugs as manufacturers learn more about exploiting biological mechanisms that fill diverse roles in the human body. Competition will become a more powerful force as manufacturers exploit biotechnology's remarkable ability to invent around successful drugs. At the same time, pricing will become ever more challenging as drugs find multiple uses involving different doses and regimens. One unpredictable element is the FDA, which is under great pressure to bridge the gap between the potential of new research methods and a regulatory regime that is in many respects slow to change. Targeted drugs often confound traditional methods for designing FDA-approved clinical trials. There is a need to explore new biomarkers, validate surrogate efficacy and safety endpoints, and encourage more adaptive and flexible clinical trial designs. Some of this could emerge from FDA changes, especially from the agency’s Critical Path initiative and its vision of collaboration among the FDA, private nonprofit organizations, and the drug industry.
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