Biogenerics at the gate waiting for the FDA to act

August 8, 2005

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.

Biopharmaceuticals are growing at almost twice the rate of total pharmaceuticals: about 350 products are in clinical testing and more than 1,000 other drugs are in early development phases. (Several terms are used interchangeably to describe biopharmaceuticals, including biologics and therapeutic proteins. Generic versions of these products are known as follow-on biologics, follow-on proteins, generic biologics, or simply as biogenerics.)

The money involved is significant. The top three biopharmaceuticals-Neupogen (filgrastim, Amgen), Epogen (epoetin alfa, Amgen), and Intron (interferon alfa-2b, Schering)-cost approximately $15,000, $10,000, and $22,000, respectively, per patient, per year, according to GPhA. Cerezyme (imiglucerase, Genzyme) a biopharmaceutical product approved for an enzyme deficiency, costs more than $170,000 per patient, per year.

Nothing will happen, however, unless the FDA acts. Some experts, including Schultz, believe FDA officials want Congress to make a move, but GPhA and others said that the FDA has the authority now under a provision of the Waxman-Hatch Amendments called section 505(b)(2). "It is true that today the FDA regulates most biopharmaceuticals under the Public Health Service Act, which is not part of Waxman-Hatch. But that act has for many years contained a provision stating that nothing shall affect the FDA's jurisdiction under the Food, Drug, and Cosmetic Act, and it is clear that FDA could regulate all biopharmaceuticals under the FDCA, as it had chosen to do for insulin and human growth hormone," said Schultz.

A significant issue for the FDA is the size and duration of clinical studies that would be required for approval of biogenerics, according to observers. "Although there are potential market opportunities for biogenerics, and any decrease in drug costs associated with biogenerics would be welcomed by governments and healthcare providers, several obstacles remain," said Faiz Kermani, Ph.D., an executive with Chiltern International, a research and marketing organization in the United Kingdom and the United States that studies the pharmaceutical industry.

"A key problem for biogenerics has been how to prove their essential similarity to the originator biotech products," said Kermani. With most pharmaceuticals, a generic manufacturer has to demonstrate bioequivalence in an Abbreviated New Drug Application (ANDA) under Waxman-Hatch, but when the law was passed in 1984, only two biotech drugs were on the market and biogenerics were not included.