Abstrakt: |
The article reports on the development of legislation which would allow generic versions of biologics to enter the U.S. market. There have been 30 generic drug proposals related to the Hatch-Waxman Act or the Medicare Prescription Drug Improvement and Modernization Act of 2003 are introduced in the 109th Congress but it had never signed into law. Meanwhile, Congress, pharmaceutical industry, and patient advocates are acting on potential solutions regarding biologics market for generic drugs. |