White House: Shield biotech drugs from generics for only seven years

Jun 29 2009

White House officials said Thursday that biotech drugs (also known as biologics) should only be protected from generics competition for seven years, Reuters reports.

"The amount of protection for brand-name companies is a sticking point among lawmakers working to set up a legal pathway for approval of generic forms of biotech drugs. The brand-name versions can cost tens of thousands of dollars per year. Industry groups representing brand-name makers are lobbying for 12 to 14 years, saying it is crucial for encouraging companies to invest in development of new medicines."

The White House, "in a letter to Rep. Henry Waxman, D-Calif., said 'seven years strikes the appropriate balance between innovation and competition by providing for seven years of exclusivity.'"

The biologic drugs are man-made versions of human proteins and treat conditions like anemia, rheumatoid arthritis and cancer, Reuters reports. The drug industry is worried that such a move will make researching and developing new drugs less attractive to drug makers (Richwine, 6/25).

Bloomberg: "Unlike conventional pills, biologics can't be copied even after patents expire. Patient groups, payers and generic drugmakers have battled biotechnology companies for more than two years over how to allow competition. … Amgen, of Thousand Oaks, California, and Genentech, a unit of Swiss drugmaker Roche, are the largest U.S. makers of biologics. They say their medicines can’t be replicated like conventional pills produced through chemical synthesis because of complex manufacturing and finished products that have slight variances ... Generic biologics may be sold at a 10 percent to 30 percent discount, allowing for 'substantial consumer savings' without eroding market share for brand-name drug companies, the Federal Trade Commission said in a June 10 report" (Larkin, 6/25).