Biotechnology drugs made by Amgen Inc. and Biogen Idec Inc. Could not be imitated and sold for lower prices for 13 1/2 years after they are commercialized, or double the time advocated by President Barack Obama, under a Senate proposition.

Americans spend more than $60 billion a year on biologic drugs to treat cancer, rheumatoid arthritis and other maladies, at a cost of as much as $200,000 per patient, Ernst & Young estimates. Generic imitations of these treatments are required to aid cut prices in the overhaul of the nation’s $2.5 trillion healthcare system, according to Obama.

The Senate proposal by Massachusetts Democrat Edward Kennedy is a procurator that may be changed or cast aside after amendments are filed today by other senators, said a senior Democratic aide to the Senate health commission who asked not to be named. Insurers, patient groups and generic-drug makers have lobbied Congress for more than two years to let the Food and Drug Administration sanction alleged biosimilars.

“At a time when policy makers are looking to lower wellness prices so more Americans can afford care, Senator Kennedy and others want to go in the opposite direction by keeping monopoly pricing,” said Katie Huffard, executive director of the Coalition for a Competitive Pharmaceutical Market, a Washington- based administration of employers, insurers and consumer groups that have lobbied for generic drugs, stated.

Biosimilars might be sold 10 percent to 30 percent below the price of the original drugs, allowing “significant consumer savings,” the Federal Trade Commission said in a June report. Makers of the brand-name therapies would retain as much as 90 percent of their market share, as they cut rates to stay competitive, the agency said.

Biologics are made from natural origins such as sugars, proteins or tissues, contrary to  established pills invented by chemical synthesis. Replicates of established pills are allowed after five to seven years under a 1984 U.S. law.

Amgen, of Thousand Oaks, California, is the largest U.S. biotechnology company, with products such as Epogen for anemia and Neupogen to boost white blood cells after chemotherapy. Both drugs have been on the market about 20 years without generic rivalry in the United States.
Demand for new products and the promise of higher margins of profit have led established drug makers to move into biotechnology. Swiss drug maker Roche Holding AG bought partner Genentech Inc., Manufacturer of the cancer drug Avastin, in March for $46.8 billion.

Brand-name biologic drugs would get at least nine years of exclusivity aside from patent protection, plus as much as four years for new uses and six months for pediatric studies under Kennedy’s plan. Drug makers led by Amgen have sought 12 to 14 years of sales before biosimilars enter the market.
White House officials offered seven years in a June 24 letter to Representative Henry Waxman, calling it a “generous compromise” with industry.

Lengthy periods of exclusivity will damage patients by diminishing innovation and unnecessarily detaining approach to low-cost drugs.