Achievable, inevitable, imperative. Those three words, insists Generic Pharmaceutical Association (GPhA) president and chief executive officer Kathleen Jaeger, describe the industry’s assessment of the need for the Food and Drug Administration to establish a scientific and legal pathway for biogenerics.


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Fine points of biogenerics are scrutinized

March 16th, 2009

NAPLES, Fla. – Achievable, inevitable, imperative. Those three words, insists Generic Pharmaceutical Association (GPhA) president and chief executive officer Kathleen Jaeger, describe the industry’s assessment of the need for the Food and Drug Administration to establish a scientific and legal pathway for biogenerics.

At the GPhA’s recent annual meeting, Jaeger referred to numerous studies demonstrating the potential savings of billions of dollars for the government, payers and patients within the first 10 years of such a system being put in place and noted that employers, labor groups and other organizations support the call for a workable pathway.

“With some biopharmaceuticals costing hundreds of thousands of dollars per year, patients must have timely access to lifesaving biogeneric medicines,’’ she told the gathering.

And such competition, contended Jaeger, not only would result in lower health care costs but also would serve to spur innovation in the biotech industry to produce new breakthrough therapies. Recently, for example, Merck & Co. announced that it would pay $130 million to buy Insmed Inc. in a transaction that includes Insmed’s portfolio of such potential products.

And in outlining his budget proposal, President Obama has called for access to less expensive versions of biotechnology drugs.

In many respects, Biotechnology Industry Organization (BIO) president and CEO Jim Greenwood concurs with a number of Jaeger’s assessments on the need for less expensive therapies and accepts the premise that such products may be — and should be — on the horizon.

But Greenwood asserts that the regulatory procedure needed should be one for follow-on biologics rather than biogenerics, noting that the difference in wording is a significant rather than subtle reflection of the division between the two health care groups on the difficult course that may evolve as government and industry work toward creating such a process. He explains that unlike a generic drug, which must be the same as an innovator product, a “follow-on” may only be similar to the innovator.

The two trade association presidents — along with attorneys Christine Siwik, a partner with Rakoczy Molino Mazzochi Siwik LLP, and Richard Kingham, a partner with Covington & Burling, LLP, who have represented GPhA and BIO, respectively, on the issue — squared off in a biogenerics panel session that occupied center stage at the annual meeting.

Jaeger concurred with Greenwood that GPhA and BIO share similar goals of bringing safe and effective medicines to the public at a reasonable cost. And the need to do so, they agreed, is paramount as the nation struggles to reduce its deficit, the economic downturn continues and the calls for health care reform intensify.

Greenwood, who served in Congress for a number of years before assuming the leadership of BIO, noted that there is “a general inclination in Washington to focus on differences that exist between political parties — a force similar to the one shaping the biogenerics/follow-on biologics debate.”

Still, Jaeger made repeated references to “the devil being in the details” as the debate over such products wages on.

A key difference is in the area of exclusivity. Greenwood contends that BIO is adamant that 14 years of data exclusivity are essential if biopharmaceutical firms are to have hope of recouping their time and expenses into product development — products he says can take years to arrive on the market (if they don’t fail in the development stages) and even longer to return a profit.

But Jaeger insisted that biologic market incentives must be consistent with the Hatch-Waxman law for traditional products.

Also entering the debate, via video remarks, was Rep. Henry Waxman (D., Calif.), who chairs the House Energy and Commerce Committee. “The brand [bio] industry is calling for 12, 14, 16 and even 20 years of exclusivity. It makes my head spin trying to keep up with their ever-changing arguments for why these terms are justified,’’ said Waxman.

But in his remarks, Greenwood disputed allegations that BIO was proposing conflicting calls for terms of exclusivity. “For biologics to receive the same length of effective market protection that small-molecule drugs receive under Hatch-Waxman, the period of data exclusivity in any FOBs [follow-on biologics] must be no less than 14 years,’’ he said.

Jaeger acknowledged that bridging the gap over exclusivity may hold the key to whether patients suffering from cancer, diabetes and other diseases eventually gain access to biogenerics.

“We know the issue of exclusivity is likely the Gordian knot that must be cut loose for us to reach consensus,’’ she conceded. “The generics industry has 25 years of experience that shows the balanced approach under Hatch-Waxman is a sound and successful model to use for biogenerics.

“We can achieve competition and innovation. We’ve done it before, and we can do it again.”

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