Generic biotech bill reintroduced

Generic biotech bill reintroduced

	Published : Thu, 15 Feb 2007 00:17 By : Agencies Print this Story

WASHINGTON (AP) - A bipartisan group of lawmakers revived a proposal Wednesday that would allow generic drug companies to market cheaper versions of biotech pharmaceuticals -- some of the most advanced and expensive medicines on the market.

Generic drug companies such as Teva Pharmaceutical Industries and Barr Pharmaceuticals Inc. have thrived over the past 20 years by releasing generic versions of traditional drugs once they lose patent protection. But in the past decade they have sought the ability to make similarly discounted versions of biotech pharmaceuticals, which differ from traditional drugs in that they are made out of proteins taken from living cells.

Amgen Inc. and Genentech Inc. lead the market for biotech pharmaceuticals.

The problem faced by makers of generic drugs is that the Food and Drug Administration does not have a system to review their biotech alternatives. Agency staffers have said the scientific complexity of the biotech products would make it particularly difficult to assure the safety and effectiveness of generic versions.

Legislation introduced in the House and Senate Wednesday would create a framework for government regulators to approve generic biotech drugs, provided they are 'interchangeable' or 'comparable' to the original products. Sponsors include Reps. Henry Waxman, D-Calif., and Jo Ann Emerson, R-Mont., and Sens. Hillary Clinton, D-N.Y., and Susan Collins, R-Maine.

Nearly identical legislation was introduced last session without ever making it out of committees. However, with the new Democratic majority focused on reining in government spending on drugs, generic drug manufacturers are hopeful the current bills may find a more receptive audience on Capitol Hill.

The Generic Pharmaceutical Association released a statement claiming generic biotech drugs could cost 10 to 25 percent less than the brand name products, saving public health programs billions of dollars.

The nation's largest biotech drug maker, Amgen, reacted ambivalently to the news, stating that generic versions of its products would have limited value for patients.

'It is not as though approval of follow-on biologics will be a huge paradigm shift,' said Amgen Vice President David Beier. 'Mainly because there are frequently already second generation versions of biological products on the market that offer superior patient value in terms of safety, convenience and efficacy.'

Beier said the drugs most likely to be affected by a law change will not go off patent for several years and urged law makers to take considerable time crafting new regulations.