Hope, Fear over generic biotech drugs.

A push is under way to allow the sale of generic versions of biotech drugs — a move supporters say could boost access to vital treatments for cancer, heart disease and other ailments, saving consumers billions of dollars a year.

It's been 25 years since biotech drugs largely were omitted from legislation permitting the first generic versions of brand-name medicines. Now the Obama administration is working to begin approving so-called generic biologics "as quickly as possible," if Congress authorizes it.

With the president promoting the idea to help trim the country's staggering health care costs, experts on both sides of the issue say pressure is building to pass such a measure.

"This is a huge issue," said David Sloane, senior vice president of government relations and advocacy for AARP, noting that drug costs are the No. 1 issue for his organization's 40 million members. "There are enormous health implications and there are enormous cost implications."

But many biotech industry leaders and some consumers, including 59-year-old cancer patient Jack Aiello of San Jose, fear the legislation could make it so hard for companies to profit from biologic treatments that it could discourage them from creating new drugs, which could wind up hurting consumers.

"I'm all for cheaper drugs when the generic versions become available," said Aiello, a former marketing executive diagnosed with multiple myeloma in 1995. "I just don't want the research efforts to be discouraged because of that."

That concern is acute in the Bay Area, which has the world's biggest cluster of biotechnology companies. Once generic biologics hit pharmacy shelves, those firms may find it harder to obtain financing to develop drugs, some executives fear.

"I think you would find a lot of questioning among people in this industry whether this is worth investing in," said Dr. David Lacey, a senior research executive at Amgen, the world's biggest biotech company, which is based in Thousand Oaks and also has Bay Area operations.

If a bill is passed, biotech executives want to make sure it keeps their confidential drug data from being made available to generic drugmakers for 14 years after their medicine is marketed. But with the White House proposing to protect that data for only seven years and some lawmakers favoring only five years, some drug industry officials fear they soon could get stuck with a law that decimates their businesses.

"There is a lot of momentum building to pass something in this Congress," said Marie Vodicka of the Pharmaceutical Research and Manufacturers of America, which represents biotech and other drug companies. "What it's about in this legislation is getting it right."

Generics tend to be cheaper than the medicines they copy because they do not have to undergo the same testing as the originals. The savings from the Hatch-Waxman Act, which permitted the sale of generics 25 years ago, has been enormous, according to an analysis in May by the market research firm IMS Health.

Commissioned by the Generic Pharmaceutical Association, it concluded that generic drugs saved the U.S. health care system $734 billion over the past decade.

The Hatch-Waxman Act only permitted generic versions of chemically synthesized drugs regulated under the Federal Food Drug and Cosmetic Act. Biologic drugs, covered under the federal Public Health Safety Act, were excluded. And many people say it's time that changed, given the growing numbers of biologics — which are made through genetic engineering or other biological processes rather than simply chemically synthesized — being approved for sale.

In 2007, about $40 billion of the nearly $287 billion that U.S. consumers spent on prescription drugs were for biologics, according to the Federal Trade Commission, which threw its support behind generic biologics in a report last month.

Some people say generic biologics are especially needed because some biologic drugs carry a high price. Avastin, a cancer drug made by the Genentech division of Roche in South San Francisco, can cost a patient $8,800 a month, although the company provides it free to some patients.

Because biologic drugs are difficult to make, some experts have raised concerns that consumers buying generic biologics might not get as close a copy as they do with generic chemically synthesized drugs.

The complexity also would make it harder and more costly to produce generic biologics. While it typically takes up to five years and up to $5 million to put a generic drug on the market today, a generic biologic would take up to 10 years and cost up to $200 million, the FTC said.

That would most likely limit the numbers of generic manufacturers jumping into the biologic market and, as a result, biotech companies "will likely continue to reap substantial profits" from their drugs. Even so, some experts have estimated that generic biologics could save consumers up to $10 billion a year.