Washington Editor

Whatever legislation Congress may finally put in place to establish a regulatory pathway for the licensure of follow-on versions of approved biologics, lawmakers must ensure that the FDA's approval process is scientifically rigorous, said Rep. Henry Waxman (D-Calif.).

But, he said, legislators should also ensure that the FDA has the flexibility it needs to make approval decisions for follow-on biologics (FOBs) on a product-by-product basis.

"We should not tie the FDA's hands and require that there be a clinical trial in every case," Waxman argued. "In some cases, this would not only waste a lot of resources, but can also put patients at risk unnecessarily. A knee jerk requirement of trials in every case would violate all ethical standards of science."

Waxman's remarks came Thursday at the Generic Pharmaceutical Association's 2007 Annual Policy Conference in Washington, D.C.

Congress has been considering legislation this year that would create a regulatory pathway for FDA to approve follow-on biologics - authority the agency currently does not possess.

Until Congress gives the FDA a pathway to approve follow-on biologics, "the biotech industry will continue to enjoy permanent monopolies untouched by generic competition," Waxman argued.

The House and Senate both have introduced follow-on biologics bills this session.

The Senate's version, the Biologics Price Competition and Innovation Act of 2007, S. 1695, was passed by the Health, Education, Labor and Pensions Committee on June 27.

However, the bill is currently a stand alone measure.

Some lawmakers have considered attaching the FOBs bill to the much larger Food and Drug Administration Revitalization Act (FDARA). That bill, now in conference committee negotiations, includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) and several other pieces of legislation affecting FDA.

Because PDUFA expires at the end of this month, FDARA is a "must-pass bill," Waxman said, noting that the most effective way to get a provision passed in Congress is to "latch it" to a must-pass bill.

But, Waxman admitted, the prospects that the FOBs, bill will be attached to the FDARA bill are "extremely slim."

Nonetheless, he declared, legislation concerning follow-on biologics is now "squarely on the table" for lawmakers.

Waxman said he is not ready to compromise on the provision in the Senate FOBs bill that would grant 12 years of data exclusivity to biotech innovator firms.

That provision, he said, would be a "huge give away" to the biotech industry.

"Brand companies should receive a reasonable term of exclusivity but not one that is so long that it would rob the American people of the cost savings appropriate that generic competition brings," Waxman contended.

He insisted that the five years granted to pharmaceutical makers under the Hatch-Waxman Act of 1984 should also be "adequate" for the biotech industry.

Waxman argued that generic competition is needed to bring down the high price of biologics. "Nothing works better than market forces" in reducing prices, he said.

The high cost of biologics, said Christopher Begley, chief executive officer of Hospira Inc., is not simply a financial issue for Congress to consider, but a moral issue for lawmakers and a "life-and-death" concern for Americans.

When life-saving biologics are not affordable, they are neither safe nor efficacious, but simply "irrelevant," he contended.

Begley noted that some biologics can cost a patient up to $200,000 per year.

Biologics cost Medicare Part B more than $5 billion last year and made up 20 percent of total Medicaid expenditures, he said.

The U.S. approval of follow-on biologics, Begley maintained, could not only save lives, but could ultimately save the nation billions of dollars. Sales of biologics rose to nearly $40 billion in 2006, accounting for 15 percent of all U.S. drug sales, he said.

Begley noted that Lake Forest, Ill.-based Hospira is actively developing six follow-on biologic products, including an erythropoiesis-stimulating agent, which the firm plans to first seek approval for in Europe.

The argument used by opponents of follow-on biologics—mostly the biotech industry—that the products are not as safe as the innovator products can "no longer hold water," said Bruce Downey, chief executive officer of Barr Pharmaceuticals.

He noted the European approval last week of Sandoz's erythropoiesis-stimulating agent.

U.S. firms are ready to produce follow-on biologics and FDA is prepared to approve those products, Downey asserted.

While FDA does have the experience and capability to approve follow-on biologics, Chief Medical Officer Janet Woodcock cautioned that the idea of "sameness" as it is applied to generic approvals of small molecules is not appropriate for complex molecules.

In biologics, Woodcock said, "Even the innovator manufacturers are not able to show sameness batch to batch."

While the science is ready for a follow-on biologics approval process in the U.S., she said, there are still many concerns about interchangeability, product naming issues, and factors influencing immunogenicity.

"A lot of these things will need to be thought through," Woodcock said.

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