Congress, patients step up campaign for more generic drugs

December 1, 2006

Washington, D.C.-While global sales of pharmaceuticals are slowing, the generic drug market continues to grow. The latest report from IMS Health predicts generic drug sales will rise 13% to 14% to $65 billion next year, almost 10% of projected worldwide drug sales of $685 billion, compared with a 5% to 6% increase in the global pharmaceutical market.

WASHINGTON, D.C.-While global sales of pharmaceuticals are slowing, the generic drug market continues to grow. The latest report from IMS Health predicts generic drug sales will rise 13% to 14% to $65 billion next year, almost 10% of projected worldwide drug sales of $685 billion, compared with a 5% to 6% increase in the global pharmaceutical market.

The prospect of added savings is driving the campaign for access to new generic treatments. A hot issue in Washington is whether the Food and Drug Administration will establish a pathway for approving generic versions of high-priced biotech therapies. And with the Democrats now setting the agenda, the campaign for generic biologics has gained impetus.

The legislation also encourages manufacturers to conduct additional testing to demonstrate that a product is "interchangeable" with the reference product, instead of just comparable. And the measure aims to prevent brand-name firms from maneuvering to extend patents and block new generics.

The bill's sponsors say that FDA set a precedent for such an approach by approving Sandoz's Omnitrope (human growth hormone) last May. FDA is somewhat reluctant, however-it took FDA nearly three years to approve this "follow-on" version of a biotech therapy, and the agency considers Omnitrope too unique to establish a pathway for other biotech products to come to market.