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.
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.
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.