"Inevitability" of biogenerics in the USA takes center stage at GPhA meeting

As the US Generic Pharmaceutical Association (GPhA) kicked-off its 25th anniversary celebration of the signing of the Hatch-Waxman Act,  Representative Henry Waxman (Democrat, California), who is House Energy  and Commerce Committee Chairman and joint orchestrator of the  legislation, told attendees that "a workable scientific regulatory and  legal pathway for biogenerics and biosimilar pharmaceuticals will ensure  more affordable medications for Americans and we believe it will spur  innovation in the biotech markets." Additionally, he argued that the  Hatch-Waxman model of market exclusivity would work well for  biogenerics.

"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 [Marketletters passim]. It makes my  head spin trying to keep up with their ever-changing arguments for why  these terms are justified," Chairman Waxman stated in video remarks to  the GPhA's annual conference. "I may be biased, but the Waxman-Hatch  model has worked well for 25 years. 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," he stressed.

Rep Waxman commits to creating an approval pathway