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Kennedy urges tough tests for generic biologic drugs

WASHINGTON -- Federal regulators charged with approving generic versions of the world's most expensive drugs should follow the lead of their cautious European counterparts, according to Senator Edward M. Kennedy . In Europe, requirements for approval are tailored to the complexity of an experimental drug and can include clinical trials that cost millions for generic manufacturers to conduct.

Tomorrow, the Senate Health, Education, Labor and Pensions Committee, which Kennedy chairs, will hear opposing views about legislation that would give the Food and Drug Administration the ability to approve generic versions of biologic drugs. Name brand biologics, which are based on living organisms, help patients suffering from serious ailments but can cost thousands of dollars per month.

On average, each day the FDA approves one new generic version of a conventional drug that is the chemical equivalent of its branded counterpart and can cost 60 percent less.

But the FDA says it lacks the regulatory power to approve generic versions of expensive specialty drugs, such as insulin , human growth hormone , and biologic therapies that treat multiple sclerosis and anemia . One estimate, disputed by the biotechnology industry, suggests that generic competition for just those four classes of specialty drugs could save $71 billion over the next 10 years .

A bill cosponsored by New York Democratic senators Charles E. Schumer and Hillary Clinton , a member of the Health, Education, Labor and Pensions panel, would open the door for lower-cost generic biologics to enter the US market. Such business leaders as General Motors Corp. and Aetna Inc. , which face staggering increases in their healthcare spending due to specialty biologics, support the legislation.

"We have a responsibility to expand the horizons of medical science in every responsible way possible so people can live longer and fuller lives," Kennedy said yesterday in a statement. "Our goal in legislation should be to enable companies to invest in new medical breakthroughs while doing all we can to cut costs for patients and protect safety."

Following Europe's example would give generic manufacturers guidance about the type of analyses and clinical trials needed to gain FDA regulatory approval, according to a Kennedy staffer.

Kennedy's willingness to require generic-biologic manufacturers to conduct clinical trials is a stance endorsed by local biotech leaders, including Genzyme Corp. and Biogen Idec Inc. Both companies sell brand-name biologic drugs and could face competition from generic versions.

"The public safety is at stake. The public confidence is at stake. You can't force the issue. You have to do it carefully," said Henri Termeer , Genzyme chief executive.

Termeer expects US regulators ultimately will follow the European example, even if it slows approval times for generic biologics. "It's very carefully considered wording where every protein -- because every protein is different -- is considered by itself."

Tim Hunt , a Biogen Idec spokesman, is among those who argue that waiving clinical trial requirements for manufacturers of generic versions of biologics is "lowering the bar on drug safety. To achieve safety, you're probably going to need to run clinical trials," Hunt said.

Schumer and other congressional backers of the bill object to the biotechnology industry's criticism.

"Safety is not an issue here. It's a bogus issue brought by those who wish to prevent change," Schumer said last month when the bill was introduced in the House and Senate. "We can be very smart about how we do this. We want the science to take the lead."

Still, if the bill that passes both houses of Congress follows Europe's lead, it could add millions to the cost of developing generic biologics.

For instance, to satisfy European regulators reviewing its application to sell a generic version of an anemia treatment, Hospira Inc. was asked to conduct a number of analytical studies, preclinical studies, and clinical trials comparing its product to branded versions.

The approval requirements were "quite burdensome," said Terry Gerrard , president of TLG Consulting Inc. and a former FDA reviewer who handled biologic approvals.

Because generic drugs have narrower profit margins than branded versions, a shift toward costly clinical trials could have a chilling impact, said Jim Bianco , chief executive of Cell Therapeutics Inc. The Seattle company recently established a spin-off company, Aequus BioPharma Inc. , to develop a technology that could speed commercialization of generic biologics.

"If the hurdles are too high, even though the markets are attractive, then one looks at the whole time-value-money consideration for where else they make their investments," Bianco said.

Diedtra Henderson can be reached at dhenderson@globe.com.

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