Washington Editor

WASHINGTON - Industry representatives on both sides of the generic biologics debate sat down for a friendly exchange here Tuesday at a one-day seminar organized to tackle potential benefits and risks associated with introducing so-called follow-on products to market.

As in recent conferences and meetings held around Capitol Hill, the consensus, particularly among government employees, suggests that follow-on or generic biologics eventually will reach market. Tuesday's event, sponsored by the Food and Drug Law Institute, raised questions of whether legislation would be necessary, or would existing regulations provide the FDA with authority it needs to clear such products? Would generic companies have to conduct clinical trials? Are biologics too complex to copy? And would generics biologics compromise patient safety?

Trade association officials representing the Biotechnology Industry Organization, the Pharmaceutical Research and Manufacturers of America and the Generic Pharmaceutical Association (GPhA) offered differing views on those questions, beginning with whether the FDA possesses authority under current law to issue such approvals.

Clearly this question is sticky, and depends on which side of the debate you're on and how your lawyers interpret it.

Panelists Steve Lawton, BIO's vice president and general counsel, and Bruce Kuhlik, PhRMA's senior vice president and general counsel, leaned toward the side that new legislation would be necessary, while Steve Bende, vice president of scientific affairs at GPhA, believes the FDA's authority is in place.

BIO worries the FDA will allow follow-on approvals of certain therapeutic protein products regulated as new drugs under the Federal Food, Drug and Cosmetic Act (FDCA), including recombinant products. Most pharmaceuticals are approved under FDCA, which carries a provision allowing abbreviated approvals for generics. Biologics, with the exception of human growth hormone and human insulin, are approved under the Public Health Service Act, which is absent generic language.

In the last couple of months BIO sent a 70-page petition to the FDA asking the agency to solicit public comment before taking any action on generic biologics. (See BioWorld Today, April 28, 2003.)

Politicians, however, are under mounting pressure to find a way to help senior citizens get access to affordable prescription drugs. This pressure, the industry fears, could translate into generic biologics that may or may not be equal to the pioneer product.

Generic pharmaceuticals are not required to undergo a rigorous clinical trial process. Rather, they only are asked to prove equivalence. The biotechnology industry said duplicating an innovative product would be more difficult, as the science behind it is more complex.

In response to that argument, Bende said, "I think if you got a bunch of scientists together, you could characterize proteins pretty darn good.

Furthermore, he said the taxpayers have invested in the biotechnology industry via the $27 billion budget of National Institutes of Health. Bende, a molecular biologist and former NIH employee, makes the argument that biotechnology and pharmaceutical companies benefit from taxpayer funding of research at the NIH.

According to Bende's research, biotechnology revenues last year were in the neighborhood of $34 billion. "This is a very healthy industry," he said, making the point that 40 percent of Phase III products are biologics.

As for the frequently quoted $800 million average cost to bring a drug to market, Bende said the figure includes a company's losses in failures, and "it doesn't matter if its $200 million or $800 million or a zillion, the risk is mitigated by the government."

Kuhlik challenged the suggestion that the industry is getting a free ride from the government. "Nothing could be farther from the truth. Drugs are discovered and developed by the industry," he said.

And if the government ends up endorsing generic biologics, Kuhlik said intellectual property rights must be considered because without that protection, investors would turn away and research likely would suffer.

Kuhlik doesn't oppose competition among drug makers. Instead, he suggested that companies wait for a product to come off patent before duplicating it.

But having only one drug on the market for a given indication is like asking for a shortage, Bende said.

When asked by an audience member whether it would be cost effective to produce generic biologics if a series of trials were required, Bende said it's difficult to guarantee prices absent a clear pathway. But even if generics were required to abide by tighter regulations for biologics compared to pharmaceuticals, Bende said savings would still exist because the generic would not have a high risk of failure. "They would go in knowing that the therapeutic worked," he said.