Biotechnology Healthcare - November/December 2008 - (Page 29) “The problem is that people get tangled up in the terminology,” believes Sara Radcliffe at BIO, the industry trade group. “There’s no regulatory definition for interchangeability, and people use it in many different ways.” try, but healthcare costs continue to rise and, as a result, the issue has certainly not receded very far into the background. “There is no reason to wait,” says Kathleen Jaeger, president of the Generic Pharmaceutical Association, the industry trade group. “What needs to happen is that we should get a bill that offers a consensus on being able to get affordable medicines to consumers sooner rather than later.” Not surprisingly, those pushing hard for legislation to create a pathway for the FDA have floated various estimates for cost savings. For instance, the Pharmaceutical Care Management Association, the trade group for pharmacy benefit managers, released a study suggesting a regulatory pathway for follow-on biologics could save Medicare Part B an estimated $14 billion over the next 10 years. And a study by Insmed — a biotech that this year became the first U.S. company to demonstrate bioequivalence for a follow-on biologic — estimated $67 to $108 billion in savings over 10 years. Insmed predicts $236 to $378 billion in savings over 20 years for versions of the top 12 categories of biologics with patents that either have expired or will expire soon. Perhaps the most significant estimate on cost savings, however, was issued last June by the U.S. Congressional Budget Office, which found that the Senate biogenerics bill — the other two proposals came from the House — would reduce total expenditures on biologics in the United States by $25 billion between 2009 and 2018. Over that 10year period, savings would equal roughly 0.5 percent of national spending on prescription drugs, valued at wholesale prices. Moreover, the bill would reduce budget deficits — or increase surpluses, depending on your point of view — by $6.6 billion over the same period. POINTS OF DEBATE Savings aside, three key points have been stumbling blocks ever since the issue emerged on the regulatory radar screen. The first is whether follow-on biologics will cause immunogenicity, or production of antibodies that may cause a follow-on biologic to be ineffective, if not unsafe. This concern is reminiscent of the argument made by brand-name pharmaceutical companies that, in certain cases, a generic product may be similar to the original drug but lacks bioequivalency, which may result in an undesirable reaction in some patients. As Secretary of Health and Human Services Michael Leavitt pointed out in a letter last year to Massachusetts Democratic Sen. Ted Kennedy, chairman of the Senate Committee on Health Education, Labor, and Pensions, “The impact of immunogenicity can be serious and life threatening.” He added that, in most cases, follow-on biologic products will not be the same as the “reference product” and their relationship to the innovator drug should not be equated to that of a generic chemical compound to a brandname medication. Leavitt went on to say that, “In addition, even if a follow-on protein product is determined to be biosimilar to the reference product, immunogenicity could preclude patients from switching from one product to another.” This leads to the second point of debate, interchangeability, or the extent to which a follow-on biologic can be substituted for the brand-name medication. Citing safety concerns raised by the prospect of immunogenicity, the biotech industry has balked at the possibility that follow-on biologics may be administered as readily as a generic pill for cholesterol is prescribed by a physician and encouraged by insurers. “The problem is that people get tangled up in the terminology,” says Sara Radcliffe, vice president for scientific and regulatory affairs at BIO. “There’s no regulatory definition for interchangeability, and people use it in many different ways. Is it therapeutic equivalence? A doctor switching medications? Or is it substitutability at the pharmacy level? Even if two products are found to be biosimilar, it’s possible that any clinical differences would still be felt by the patient. In our view, patients should be given the biologic expressly prescribed by their physicians.” “If the FDA doesn’t come up with interchangeability criteria — and I estimate that it will take some time — you may have to market a product as a follow-on biologic, and not as a generic substitution,” says Steve Russek, chief clinical officer at Accredo, the specialty pharmaceutical arm of pharmacy benefit manager Medco Health Solutions. NOVEMBER/DECEMBER 2008 · BIOTECHNOLOGY HEALTHCARE 29
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