Henry Waxman this week told attendees of the Generic Pharmaceutical Association Annual in Florida that he would work to pass legislation that would allow generic versions of biogenerics and biosimilar pharmaceuticals.
Sen. Henry Waxman (D-CA) told attendees of the Generic Pharmaceutical Association Annual Meeting in Florida this week that he would work to pass legislation that would allow generic versions of biogenerics and biosimilar pharmaceuticals.
Speaking by video to the gathering in Naples, Fla., Waxman said that just as the Hatch-Waxman Act -- adopted 25 years ago -- has saved Americans billions of dollars, similar legislation addressing biogenerics would benefit consumers.
“One of the biggest sticking points in the debate over biogeneric legislation will be the number of years of exclusivity to which brand companies are entitled. The brand industry is calling for 12, 14, 16, and even 20 years of exclusivity,” said Waxman. “It makes my head spin, trying to keep up with their ever-changing arguments for why these terms are justified,” he said.
“I may be biased, but the Waxman-Hatch model has worked well for 25 years,” he added. “It achieves a strong balance between fostering innovation and making affordable medicines available to consumers. There is no reason why this same balance cannot be achieved with biogenerics.”
Following Waxman’s remarks, CEOs of generics industry companies participated in a panel discussion, reiterating their opinion that Congress needs to pass biogenerics legislation to bring competition into the biopharmaceutical sector and lower health-care costs.
GPhA President and CEO Kathleen Jaeger said that biogenerics legislation has gained momentum, but she conceded that the brand industry and the generics industry disagree on the specifics of such legislation. “The devil is in the details,” she said.