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Does generic entry always increase consumer welfare?
(Food Drug Law J, 2012)
This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into ...
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 ...
Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.
(Health Aff (Millwood), 2011-11)
The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. ...