Now showing items 1-4 of 4
Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
(Health Aff (Millwood), 2014-06)
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing ...
Economic return of clinical trials performed under the pediatric exclusivity program.
CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric ...
Returns to R&D on new drug introductions in the 1980s.
(J Health Econ, 1994-12)
This study finds that the mean IRR for 1980-84 U.S. new drug introductions is 11.1%, and the mean NPV is 22 million (1990 dollars). The distribution of returns is highly skewed. The results are robust to plausible changes ...
Developing drugs for developing countries.
(Health Aff (Millwood), 2006-03)
Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments ...