US Rep. Henry Waxman plans to introduce Congressional legislation as early as this fall to create a framework to approve “biosimilar” or generic biologic drugs, according to published reports.
During a speech given today at the Generic Pharmaceutical Association's annual policy convention, Waxman said, “Patients who need these drugs pay tens of thousands of dollars. Can you imagine paying for them if you have no health insurance? We have to do something to get generic biologics on the market as soon as possible.”
US Sen. Orrin Hatch is also reported to be working on similar legislation in the Senate although a timetable has not been set for his proposal.
In 1984, Hatch and Waxman wrote the law that created the approval system for generic forms of traditional pharmaceuticals.
Currently, there is no system in place in the US to approve substitute versions of biotechnology drugs.