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CU to Senate: Guide FDA to promptly establish pathway for approval of safe biogenerics

July 19, 2006
The Honorable Gordon Smith
Chairman, Committee on Aging
United States Senate
Washington, DC 20510
Dear Chairman Smith:
As the Senate Committee on Aging studies the issue of generic drugs, Consumers Union, the independent, non-profit publisher of Consumer Reports, hopes you will consider the topic of generic biologics, otherwise known as biogenerics or follow-on protein products. In particular, we urge you to guide the FDA to promptly establish a pathway for the approval of safe biogenerics.
As the last twenty-five years have shown, biologics are amazing drugs. These medicines, which are molecules derived from living organisms and not just chemicals, provide treatments for conditions ranging from growth abnormalities to cancer. They are revolutionary and their contribution to medicine will only continue to increase.
Nevertheless, the financial burden that biologics pose to the American consumer and the federal government through its Medicare Part D prescription drug benefit and the Medicaid program cannot be underestimated. Biologics routinely cost upwards of $10,000 for a year’s treatment.1 Less common treatments, such as Avastin, a colon cancer therapy, cost as much as $49,000 for a ten month course.2 These financial costs may be moderated, though, through biogenerics. With an estimated $10 billion worth of these drugs coming off patent by 2011, there is a great opportunity to use generics to reduce the cost of biologics for the consumer and the government.3
Much of the delay on biogenerics is attributed to safety concerns. Given their highly specific allergic profiles, biologics pose a greater danger for adverse reactions in patients than do standard chemical drugs. These concerns can be addressed if biogenerics are subject to extensive non-clinical and limited clinical trials. Indeed, such an approach has been adopted in Europe, where, just this year, the European Medicines’ agency (EMEA) released comprehensive guidelines for the approval and regulation of biogenerics. The European approach has been simple. First, they released a general, overarching guideline that specifies the kinds of non-clinical and clinical trials that all protein products would need to undergo to demonstrate efficacy and safety.4 Second, they have been progressively releasing additional product-specific amendments that give detailed criteria for testing and approval. For example, in February of this year, the agency adopted an annex guideline on human growth hormone5 and a month later, one on epoetin.6 The agency plans to release additional guidelines about other classes of drugs.
In contrast, no abbreviated biogenerics’ approval pathway has been put in place in the United States. While the FDA has conceded that the simple biologics regulated under the Federal Food, Drug, and Cosmetic act (FDCA), such as growth hormone and epoetin, can be approved, it has offered no guidance about how generic versions of such drugs should be manufactured and tested. Additionally, the agency has argued that it has no legal authority to create a similar pathway for the majority of biologic drugs, which are regulated under the Public Health Service (PHS) Act. As the FDA will not act on the topic of biogenerics without Congressional guidance, it is imperative that Congress provide direction on this issue. 7
Consumers Union is deeply committed to protecting the consumers’ health, well-being, and finances. The European Medicines’ Agency’s example offers compelling evidence that safe, cost-saving biogenerics can be made. We hope that you and the Committee on Aging will take timely action and prompt the FDA to establish a timeline for releasing guidelines for the approval and regulation of biogenerics.
Thank you for your consideration of this point.
William Vaughan
Senior Policy Analyst
Anuradha Phadke
Staff Assistant
1 Statement of Senator Orrin Hatch on June 23, 2004. Hearing entitled, “The Law of Biologic Medicine.”
2 “The Growth of Generic Drugs.” 31 Jan. 2006. Red Herring. 5 July 2006. < http://www.redherring.com/.>
3 “FDA Looks at Biogeneric Issue, but Action Unlikely in Near Term.” 10 Nov. 2004. Specialty Pharmacy News. 10 July 2006.
Msup>4 EMEA/CHMP/42832/05 Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substances: Non-clinical and Clinical Issues. (CHMP adopted February 2006).
5 EMEA/CHMP/94528/05 Annex Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues – Guidance on Similar Medicinal Products containing Somatropin (CHMP adopted February 2006).
6 EMEA/CHMP/94526/05 Annex Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues – Guidance on Similar Medicinal Products containing Recombinant Erythropoietins (CHMP adopted March 2006).
7 “Omnitrope (somatropin [rDNA origin]): Questions and Answers.” 30 May 2006. US Food and Drug Administration. 6 July 2006.