
Generic drug manufacturers are in a high-stakes waiting game with the Food & Drug Administration, anxious to act once the agency outlines an application process for the creation of generic equivalents to biopharmaceuticals. "We are at a similar crossroads today with respect to generic biopharmaceuticals as we were in 1984 with respect to traditional pharmaceuticals," said attorney William B. Schultz, a partner with Zuckerman Spaeder in Washington, D.C. He has testified before Congress on behalf of the Generic Pharmaceutical Association about the laws governing biologic medicine. "The generic pharmaceutical industry is convinced the savings resulting from competition can be applied to the biopharmaceutical industry," he said.