FDA Approves First Biogeneric Drug--Or Does It?
Sandoz announced Wednesday that the FDA has approved Omnitrope, Sandoz's recombinant human growth hormone drug product. According to Sandoz's press release, the FDA approval is "precedent-setting" because Omnitrope is the first "follow-on version of a previously approved recombinant biotechnology drug" (or "biogeneric"). Omnitrope is similar to Pfizer's Genotropin.
The FDA, however, disputes Sandoz's claim. According to a FDA Question and Answer sheet released on Tuesday, Omnitrope is not a generic biologic because it "is not rated as therapeutically equivalent to (and therefore substitutable for) any of the other approved human growth hormone products." The Q&A sheet states, "Omnitrope is more appropriately characterized as a 'follow-on protein product,'" several of which have previously been approved by the FDA.
Moreover, according to the FDA, the approval of Omnitrope does NOT create a new pathway for biogenerics. The agency states: "There is no abbreviated approval pathway analogous to 505(b)(2) or 505(j) of the [Food, Drug, and Cosmetic] Act for protein products." The FDA believes that such approval would require new legislation.
FDA approval of Omnitrope follows an April 10, 2006, decision by the U.S. District Court for the District of Columbia requiring the FDA to make a decision on Sandoz's Omnitrope application, which had been held up for years.
GPhA, the trade group representing generic drug makers, released a statement hailing the FDA's decision to approve Omnitrope, though PhRMA, the trade group representing innovator drug companies, released no statement one way or the other.
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