Debate over follow-on biologic legislation continues

At the 2009 annual meeting of the Generic Pharmaceutical Association (GPhA) in February, House Energy and Commerce Committee Chairman Henry Waxman told attendees that a workable scientific, regulatory, and legal pathway for follow-on biologics (also referred to as biogenerics or biosimilar pharmaceuticals) would lead to more affordable medications for Americans.

“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. It makes my head spin trying to keep up with their ever-changing arguments for why these terms are justified,” Waxman stated in video remarks at the meeting.

“I may be biased, but the Waxman-Hatch model has worked well for 25 years,” he continued. “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, expressing their opinion that Congress needs to pass legislation regarding follow-on biologics to bring competition into the biopharmaceutical sector and lower healthcare costs.

These comments were reiterated by GPhA President and CEO Kathleen Jaeger during a follow-up panel discussion with Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood. Both Jaeger and Greenwood agreed that legislation regarding follow-on biologics has gained momentum, but as Jaeger noted, debates are ensuing over the details.

Greenwood reiterated BIO’s position that there should be 14 years of market exclusivity for the innovator biologic.

Jaeger emphasized that what has become clear during the debate is that “biogenerics are achievable, imperative, and inevitable.” Jaeger pointed out that no fewer than 42 companies are actively engaged in follow-on biologic development and that FDA has clearly stated that the science exists to ensure the safety and efficacy of these products.

Greenwood concluded that he was confident that “we’ll find enough common ground to serve patients.”