Larry Deeb
|
Diabetes is a deadly, common and costly disease, so the debate about biogenerics is ardent when it concerns insulin. The drug
is expensive and indispensable, and scientists agree that creating generic insulin is simpler than creating most other potential
biologic equivalents. Yet nearly a quarter century after the Waxman-Hatch Amendment, no legal pathway for approval of generic
biologics exists.
Six years ago, the Food & Drug Administration said it would soon issue guidelines for approval of generic insulin, treating
the drug (along with human growth hormone, or HGH) as an exception. On Feb. 10, the agency announced that guidance would not
be forthcoming, at least not for a while. Four days later, Congress reacted with proposed legislation that forced the FDA's
hand.
Sara Radcliffe
|
That could be a good move, according to diabetes experts, who believe generic insulin is potentially invaluable. "Successful
diabetes management depends on patient access to and compliance with a prescribed drug regimen," said Larry Deeb, M.D., president
of medicine and science, American Diabetes Association. "One way of improving access and reducing costs is the use of generic
drugs, if they are proven to be medically safe and effective."
But Sara Radcliffe, VP for scientific and regulatory affairs of the Biotechnology Industry Organization (BIO), which represents
the industry, said, "No one is arguing that there is no potential value in financially available forms of insulin. The pressing
issue is safety and effectiveness. The complexity of biopharmaceuticals is far greater than that of other drugs. While insulin
relies on small nonglycosylated proteins, it doesn't mean it is simple to make an insulin product." And "even small differences in these products can cause differences in effectiveness and unexpected side effects," agreed
Kelley Davenport, director of corporate communications for Amgen, whose share of the biopharmaceutical market approaches $10
billion annually, according to IMS Health.
Several generic drugmakers have already begun developing generic versions of biopharmaceuticals because patents on brand drugs
have expired, or are soon about to.
The insulin market in this country is dominated by Eli Lilly (Humulin), Novo Nordisk (Novolin), and Sanofi-Aventis (Lantus).
Humulin and Novolin have already lost much of their patent protection.
In June 2006, the FDA approved Omnitrope (somatropin recombinant), an HGH made by Sandoz. The degree of complexity in HGH
molecules is comparatively simple, as is the case with insulin. "That shows that this approach is scientifically feasible,"
said Rep. Henry Waxman (D, Calif.).
The legislation—sponsored by Charles Schumer (D, N.Y.), Hillary Rodham Clinton (D, N.Y.), Waxman, and colleagues—is named
the Access to Life-Saving Medicine Act. It would essentially expand Waxman-Hatch to include biologics. It does recognize,
however, that because biotech drugs are produced from living cell cultures, their generic versions are more chemically complicated
than those of traditional drugs. So the proposed law establishes a stipulation for case-by-case approval of the products.
In February, 11 governors contacted the FDA, demanding that it ease the way for the production and sale of generic insulin.
"Biological drugs are so expensive that we need to push the FDA on this," said Sen. David Vitter (R, La.) in a public statement
supporting the new legislation, adding that diabetes is crippling his state's Medicaid program.
The problem, say Waxman and others, is that, notwithstanding its approval of an Omnitrope equivalent, the FDA won't issue
statutory pathways for generic versions of biotech drugs to enter the market after relevant patents have expired. That's why
he is sponsoring legislation to force the agency to create abbreviated pathways for biogenerics.
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