Why so long? FDA deputy commish Janet Woodcock told a House committee today that human tests are needed before copycats can be considered interchangeable. The reason is a lack of knowledge about protein-based drugs to rely exclusively on analytical studies suggesting generics work the same way in patients.

“The problem with the follow-on proteins is that it’s very difficult to say we have the exact same molecule because it’s a complicated molecule,” Woodcock testified at the before the House Committee on Oversight and Government Reform, which is chaired by Henry Waxman. “Scientific techniques are not available to demonstrate sameness for these molecules.”

An exec Novo Nordisk, a biotech company that makes diabetes treatments, agreed. Inger Mollerup said that if Congress creates a system to approve cheaper protein-based drugs it should be similar to one already used by the European Union.

Under the EU system, generic biotech companies have to conduct extensive studies to show the safety of their versions. Even after these studies are completed and the product is approved, knockoff biotech drugs are not considered interchangeable with the original product, meaning a patient has to get doctor approval before switching from the original drug to a generic.

Waxman has been pushing the FDA to create so-called pathway to approve generic biotechs as a way to lower health care costs, but the move has run into resistance from established biotech companies that fear competition and argue patient safety may be compromised.

List of witnesses and their testimony;
Reports from the Associated Press and Bloomberg News.[tags]Amgen, FDA, Genentech, Generic Biotechs, Henry Waxman, Janet Woodcock[/tags]