New Rules On Generic Biological Medicines Under US Congressional Debate
By Liza Porteus Viana for Intellectual Property Watch
When Biotechnology Industry Organization CEO Jim Greenwood meets with members of the United States Congress to talk to them about follow-on biologics, he brings a graphic model of an aspirin and a DVD showing the complex molecules of a biologic drug. He uses these visuals to help explain the differences between traditional chemical drugs and newer, cutting-edge biological ones being used in many breakthrough therapies for cancer, multiple sclerosis, HIV/AIDS, and other diseases.
The differences between traditional chemical drugs and biological ones is the crux of the debate going on in the United States as Congress and the Food and Drug Administration (FDA) try to create a regulatory pathway that gives consumers greater access to cheaper, generic biological drugs, but still spurs innovation and protects innovator patent claims.
"When the legislation was introduced at the beginning of this Congress, most pundits expected that we'd oppose it," said Greenwood, a former House representative from Pennsylvania, told Intellectual Property Watch. "But that was a mistake the pharmaceutical industry made in the '80s - trying to resist the notion you could safely make generics …our view at BIO is that we need to follow the science, and science says you can make follow-on biologics that can be safe and can save the consumer money and therefore we support it."