A Message from Kathleen Jaeger: FDA Needs to Support Generic Biologics

Kathleen Jaeger, GPhA president and chief executive officer
Published Online: Thursday, June 1, 2006

It was disturbing to read recently that Genentech decided to increase the price of Avastin (bevacizumab), a biopharmaceutical product used to treat colon cancer, to $100,000 per year. Avastin has no competitors, allowing Genentech to set the price at whatever the market will bear. As the cost of this medicine increases for patients, so will the cost to insurers, health care programs such as Medicare and Medicaid, and the health care system in general.

The recent approval by the FDA of Sandoz's Omnitrope human growth hormone represented a significant first step in bringing more affordable biopharmaceuticals to the US marketplace. This decision clearly demonstrates that sound science exists to support the approval of generic biopharmaceuticals despite assertions from special interests to the contrary. It demonstrates that generic companies can develop safe and effective biopharmaceutical products. It demonstrates that the FDA already has the authority to approve such products. And it brings our nation one step closer to the day when generic versions of expensive biopharmaceuticals will be readily available.

Scientific support for generic biopharmaceuticals was further bolstered in May 2005 with the publication of the US Pharmacopeia's (USP) monograph that addresses product-quality standards for somatropin, a human growth hormone. By publishing this monograph, the USP indicated that a biopharmaceutical product could be characterized and standards established, despite the brand sector's claims to the contrary.

Recent actions in Australia and the European Union (EU) further confirmed the science and safety of generic biopharmaceuticals. Already, generic human growth hormone has been on the market for nearly a year in Australia, and the EU approved the same medicine in April 2006. Both Australia and the EU have approval processes in place for generic biopharmaceuticals. By contrast, the United States is far behind.

GPhA strongly believes that it is possible, under the FDA's current structure, to permit approvals and marketing of a vast array of generic biopharmaceuticals with relatively low to modest complexity, and to expand that system in the coming years to permit the approval of more complex products as sound science evolves. The FDA approval of Omnitrope supports our position.

For several years, the FDA has pledged to address the approval process through the release of a white paper along with draft guidances on policy, chemistry, manufacturing and controls, and immunogenicity. To date, no action has been taken. Members of Congress have noticed the delay. Sen Orrin Hatch (R, Utah) and Rep Henry Waxman (D, Calif) inquired why these documents, as well as the review of an application for a generic human growth hormone, were stalled for about 3 years. The FDA responded to their inquiry by stating that the agency is now considering the development of broader guidance documents, even though it had flatly rejected this approach years earlier on the grounds of lack of industry value. It appears that these documents are being delayed for political reasons, not scientific ones.

The use of biotech medicines is increasing, and marketed biologic products are growing at a rate of 17% annually, with no signs of slowing. Already, biopharmaceuticals comprise a growing percentage of Medicare and Medicaid costs. Members of Congress have recognized the problem of burgeoning costs, with one senator noting that, "if we don't explore prudent steps to encouraging generic biologics, drug prices may rise so much that it would endanger Medicare itself."

It is time for Congress to ensure that the FDA will take those prudent steps. The FDA should not be denying US citizens—and the health care system—similar savings through the approval of generic biopharmaceuticals.




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