Surging demand for specialty Rx may be problematic for retail

Drug Store News, August 13, 2007 by Jim Frederick

Also driving the biotech market is the growing push for generic versions of bio-engineered drugs. Members of Congress are under pressure from budget-minded health care advocates, the generic industry and some activist lawmakers themselves to pass legislation mandating that the Food and Drug Administration open an abbreviated approval path way for generic biopharmaceuticals.

In response, a broad gamut of influential lawmakers--ranging from such liberal Democrats as Sen. Edward Kennedy of Massachusetts, Sen. Debbie Stabenow of Michigan and Rep. Henry Waxman of California, to such conservative Republicans as Sen. Orrin Hatch of Utah and Sen. Trent Lott of Mississippi, have voiced support for legislation that seeks to create a clear regulatory pathway for follow-on biologics, or biogenerics.

"The science and the economics lead to the same conclusion: the time has come to establish a pathway for approving generic versions of biopharmaceuticals," Waxman told generic industry leaders earlier this year. "Congress can no longer stand by and watch as our reliance on biologics increases, along with their costs."

In the midst of the political groundswell for a biogeneric approval pathway, the FDA did clear for marketing one biosimilar drug last year--a human growth hormone branded as Omnitrope from Sandoz--under a narrow interpretation of existing review and approval procedures, according to IMS. The research company called that move a landmark decision, and noted it "provides a narrow opening for other biosimilars."

This new era of highly targeted and specialized medications could reduce the number of blockbuster drugs reaching the market, according to one expert. Writing in the New England Journal of Medicine, David Cutler, Ph.D., noted that pharmaceutical companies are likely to aim their future R&D efforts in such drug classes as selective serotonin-reuptake inhibitors in a more and more targeted way to more effectively treat different groups of patients who respond differently to various drugs within the SSRI class of medications.

"The blockbuster model relies on the proposition that the same drug is good for everyone--that one size fits all," Cutler reported in a recent article in the prestigious medical journal. "But even drugs with similar average efficacy do not have the same effect for all."

In the case of SSRIs, for example, "the response to each drug is idiosyncratic and unpredictable" among different patients with depression, Cutler pointed out.

"Someday, genetic science may tell us why some patients are more responsive than others," he noted. "When that happens and drugs can be targeted more accurately to patients likely to have the desired response, the market for any particular SSRI will shrink."

It follows, Cutler wrote, that "In the new era, physicians might have to conduct genetic or biochemical analysis to determine which medication is the appropriate one" for patients, "before prescribing a medication." In addition, he noted, "As molecules are increasingly targeted to niche markets, pre-approval study populations will necessarily shrink, and the need to monitor how drugs actually work after approval will intensify."