European Official Urges Caution on Generic Biologics

Caution urged on biologic drugs

By Diedtra Henderson, Globe Staff | March 8, 2007

WASHINGTON -- European regulators told a Congressional panel today that some biological drugs -- such as insulin and human growth hormones -- are simple enough to produce in generic versions, but others are too complex to be safely duplicated.

Generic versions of certain biologics have been allowed in Europe for the last four years, but approval came only after manufacturers conducted rigorous human clinical trials. European regulators recommended today that the United States adopt the same standards.

The testimony came during a Senate Health, Education, Labor and Pensions committee that is considering a bill to permit United States regulators to approve generic versions of biologics, drugs based on living organisms and cells.

Too much flexibility for generic manufacturers in Europe would have “spread suspicion” that the generic biologic products were unsafe, said Nicolas Rossignol, who is responsible for implementing the European Commission’s legislation governing generic biologics. Rossignol testified from Brussels.

Senator Edward M. Kennedy, who chairs the committee, called biologic drugs “miracle medicines” that can come at a steep price to the healthcare system tens to hundreds of thousands of dollars annually per patient. Americans spent an estimated $60 billion on such products last year, according to IMS Health, a healthcare information company, compared with $53 billion in 2005.

Generics that are chemical equivalents to conventional drugs save Americans at least $10 billion per year. The Food and Drug Administration, however, lacks the legal ability to approve generic versions of biologics.

Kennedy, Democrat of Massachusetts, said such legislation should be “led by the science,” while protecting patient safety and valuing the investments made by innovator companies.

Opponents of the current measure, including Senator Orrin Hatch, Republican of Utah, say it lowers safety standards and could imperil patients. Hatch cosponsored legislation that speeds to market generic versions of conventional drugs. He favors requiring that prospective generic biologic manufacturers test their drugs in humans before approval. Hatch also supports establishing patient registries to track side effects that may not occur until years after patients start using a product.

“What we need to do is keep working to get the best legislation,” Hatch said.