Issue Date: July 20, 2009
Senate Moves On Generic Biologics
The Senate Health, Education, Labor & Pensions (HELP) Committee approved an amendment on July 13 that would create a pathway for FDA to approve generic biologic drugs. The Biologics Price Competition & Innovation Act of 2009, introduced by Sens. Mike Enzi (R-Wyo.), Orrin Hatch (R-Utah), and Kay Hagan (D-N.C.), would provide 12 years of market exclusivity for biologics so that biotech companies can recoup the cost of developing the drugs. Biologic drugs are proteins produced by living organisms rather than by chemical synthesis and are therefore expensive and complex. Various proposals have been introduced to bring lower cost generic biologics to market, but there has been intense debate over how long a biologic should be marketed without competition from generic versions. The 12-year exclusivity amendment is now part of a larger health care overhaul bill, the Affordable Health Choices Act, which was approved on July 15 by the Senate HELP Committee. The Biotechnology Industry Organization called the passage of the amendment a victory for patients. The House is still debating the issue, and the Obama Administration is pushing for a seven-year exclusivity period.
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