- The Washington Times - Thursday, February 15, 2007

The new Democratic-controlled Congress is pushing to allow generic versions of costly biological drugs on the U.S. market for the first time.

Rep. Henry A. Waxman, California Democrat and chairman of the Committee on Oversight and Government Reform along with Sen. Charles E. Schumer, New York Democrat, introduced legislation this week that would open the door for the Food and Drug Administration to approve cheaper, generic counterparts to biological drugs.

“The burden of paying for biotech medicines on employers, insurers, and the federal government is staggering,” said Mr. Waxman while introducing the bill.

But the amount of money approval for generic biological drugs would save is hard to pinpoint — the Congressional Budget Office has not scored the bill — because it is impossible to exactly duplicate such a drug. Biological drugs can treat cancer, diabetes and multiple sclerosis and are made from living organisms, such as proteins, as opposed to chemical-based prescription drugs. Therefore it is difficult for federal regulators to know for sure that a biogeneric is clinically equivalent to the branded drug.

If the bill is successful, generic biologics or ‘follow-on-biologics’ will have a significant effect on competition and pricing of the protein-based therapeutics. According to IMS Health, a pharmaceutical and biotech consulting firm, biological drug sales jumped 17.1 percent in 2005, generating $52.7 billion. And growth in biologics is expected to reach $90 billion by 2009, three times faster than prescription drugs.

Generic-drug makers such as Sandoz and Teva Pharmaceuticals are ready to pounce on the untapped bio-drug market. And Barr Pharmaceuticals Inc. has several generic biologics in the pipeline, according to the firm’s chief executive, Bruce Downey.

Beyond a new regulatory pathway for biogenerics lies another hurdle: patents. Because biological drugs are relatively new and U.S. patent laws are more lenient than in other countries, generic-drug companies will likely struggle, at least early on, to get their drugs to market. For instance, the top dialysis drug, Epogen, made by Amgen, doesn’t go off patent until 2012.

“Because the biotechnology medicines that will be most affected by follow-on biologics legislation do not go off patent for several years, there is sufficient time to have a thoughtful and fact-based dialogue,” said Kelly Davenport, director of corporate communications at Amgen, a leading biotech company in California.

Biotechnology companies and generic-drug companies will lock horns over whether enhanced safety and effectiveness testing should be included in the bill.

David Beier, vice president of global government affairs at Amgen, said the legislation must require generic-drug companies to conduct clinical trials on the generic version as well as include a time period — around 10 years — of market exclusivity for the brand-name biologic.

That type of system would closely resemble the European Union’s regulatory framework for biogenerics, which generic-drug companies contend is too stringent.

Health care runs Fridays. Contact Gregory Lopes at 202/636-4892 or glopes@wash ingtontimes.com

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