Now It’s time for Generic Biologics, Too

(Washington, DC)-The American health care system saved more than $734 billion through the use of generic medicines over the last decade, according to a new national study released today by the Generic Pharmaceutical Association (GPhA).  The new independent economic analysis conducted by IMS Health highlights the value of this important cost-saving tool utilized by pharmacy benefit managers (PBMs) in Medicare and the commercial sector, the Pharmaceutical Care Management Association (PCMA) said today.

“Since 1984, the potential for generics to offer savings has been routinely underestimated.  PBMs and others have consistently found new and innovative ways to promote generic utilization and competition in the prescription drug marketplace.

“Now, many underestimate the ability of generic biologics to save money. It’s time to create a regulatory pathway for the Food and Drug Administration (FDA) to approve generic versions of biologic products,” said PCMA President and CEO Mark Merritt.

PCMA strongly supports the bipartisan “Promoting Innovation and Access to Life-Saving Medicine Act” (H.R. 1427) introduced by U.S. House Energy and Commerce Committee Chairman Henry Waxman (D-CA), Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO), which would create a regulatory pathway for the Food and Drug Administration (FDA) to approve generic versions of biologic products.   Companion legislation was introduced in the U.S. Senate (S. 726) by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), David Vitter (R-LA), Debbie Stabenow (D-MI),  Jeanne Shaheen (D-NH), and Mel Martinez (R-FL). 

This legislation would give brand-name biologics five years of exclusivity before generic versions could enter the market and would generate greater savings to fund broader health reforms, in contrast to the competing House bill (H.R. 1548), which would give brand-name biologic manufacturers up to an unprecedented 14 years of exclusivity before generic versions could hit the market.

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