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Legislation would allow generic biotech drugs in US

Lawmakers in the US House and Senate introduced legislation that would for the first time routinely allow copies of medicines made using biotechnology.

The measures offered yesterday would permit generic drugmakers, such as Barr Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd., to produce medications that are now off-limits to competition. Generic biotech drugs could reduce prices by almost a third and cut into the profits of brand-name biotech companies such as Amgen Inc. and Genentech Inc., analysts said.
The medications include some of the costliest on the market. „Without action, the manufacturers of these biotech drugs can continue to charge monopoly prices indefinitely,” Senator Hillary Clinton, a Democrat from New York and presidential candidate, said at a news conference in Washington. „Biotech drugs hold great promise, but we break that promise when the costs push treatments out of reach.”
Sponsors of the measure in the House include Henry Waxman, a Democrat from California, and Jo Ann Emerson, a Republican from Missouri. Backers of a matching Senate version include Clinton and Charles Schumer, also a Democrat from New York.

Opponents said attempts to copy complex gene-based medications could pose health risks. Passage of the legislation „may mean that these drugs come onto the market without the testing necessary to make sure they are safe and effective,” said Paul Winters, a spokesman for the Biotechnology Industry Organization, or BIO, a Washington-based group that represents makers of brand-name biotech drugs.
Lawmakers introduced similar legislation last year that didn't advance in the Republican-controlled Congress. Supporters say prospects have improved with Democrats in control. US law allows the Food and Drug Administration to approve generic versions of conventional drugs, made mostly through chemical synthesis, after patents expire. There is no similar process for most biotech medicines, genetically engineered versions of human proteins such as insulin or growth hormone.
Biotech drugs generated revenue of about $32.8 billion, 13% of the $251.8 billion in prescription sales to US pharmacies in 2005, according to IMS Health Inc., a research company in Fairfield, Connecticut. Many biotech medicines carry high price tags, and generic versions could lower prices by 20% to 30%, Elise Wang, an analyst with Citigroup Inc. in New York, said in an interview. One of the most expensive biotech medicines is Genzyme Corp.'s Cerezyme, a treatment for a rare enzyme disorder that can cost $200,000 a year.

Generic biotech medications could save sponsors of US health plans, including employers and the federal government, $71 billion over 10 years, according to Express Scripts Inc., a manager of prescription drug benefits based in Maryland Heights, Missouri. About $3.5 billion of the savings could come in the first year generics are sold.
Barr of Woodcliff Lake, New Jersey, says in lobbying literature that patents have already expired for some top-selling biotech medications, making them vulnerable to competition if lawmakers act. Among the products listed is an anemia treatment sold in the US by Amgen as Epogen and by Johnson & Johnson as Procrit. US sales of the drugs, sold by both companies under a marketing agreement, totaled $4.71 billion in 2005.

Amgen and Johnson & Johnson say patents continue to protect the products from competition. A report from Citigroup says that one of Amgen's patents lapsed in 2004 and others expire in 2012 through 2015. Conventional drugs are small molecules that generic makers can reproduce in versions that are almost identical to the original product and change little from batch to batch. Biotech medications use bacterial cells to produce human proteins, and the final composition can vary, depending on the techniques used.
The legislation would permit the FDA to decide whether generic makers can skip or abbreviate human clinical trials, and supporters say that the agency would make sure the copies are safe. Clinical trials generally aren't required for copies of conventional drugs. Proponents of the legislation use the term „generics” for the biotech drugs they want to reproduce. Some brand-name makers say the drugs should be called „follow-on biologics” because the new versions aren't identical. European regulators call them „biosimilars.” (Bloomberg)