Obama 2012 Budget Proposal Reduces Exclusivity For Biologics

Shortly after passage last year of the US healthcare reform act called for a regulatory pathway to bring follow-on biologic drugs, or biosimilars, to market with 12 years of data exclusivity for brand-name producers, the Obama administration has proposed to reduce that time to its original 7 years, according to sources. The move, contained in the 2012 budget proposal, is expected to allow lower priced generic versions of drugs to enter the market sooner, a benefit to consumers.

The Pharmaceutical Research and Manufacturers Association (PhRMA) issued a statement criticising the move as potentially undermining research in this area. Concerns had been raised in recent weeks over the effect on patients of the unusually long exclusivity period (IPW, US Policy, 28 January 2011).