The U.S. Food and Drug Administration has approved Novartis AG’s Omnitrope hormone in what could mark a sea change in the stance taken by the FDA on generic biotechnology drugs. This precedent setting event marks the first follow-on version of a previously approved recombinant biotechnology drug in the U.S.

Earlier, a federal judge ordered the FDA to decide after a long delay whether Sandoz can market a version of human growth hormone as a bioequivalent to the one already sold by Pfizer Inc. Sandoz, the generics arm of Novartis, sued the FDA last September for leaving its application for a generic approval in limbo, a move designed to break a stalemate over so-called biogenerics. Under both the Federal Food Drug and Cosmetic Act and the Food Prescription Drug User Fee Act, the FDA is required to either approve or reject new drug applications.

The FDA, however, went out of its way to say the Omnitrope case is not precedent setting, even putting out a question-and-answer sheet to indicate that Omnitrope is not a generic biologic:

Is Omnitrope a generic biologic?

No. Omnitrope is not rated as therapeutically equivalent to (and therefore substitutable for) any of the other approved human growth hormone products. Omnitrope is more appropriately characterized as a “follow-on protein product.”

Is this FDA’s first approval of a follow-on protein product?

No. FDA has approved other follow-on protein products under section 505 of the Food, Drug, and Cosmetic Act. These include GlucaGen (glucagon recombinant for injection), Hylenex (hyaluronidase recombinant human), Hydase and Amphadase (hyaluronidase), and Fortical (calcitonin salmon recombinant) Nasal Spray.

Does today’s approval of Omnitrope create a new pathway for follow-on versions of all protein products?

No. The approval of Omnitrope in a 505(b)(2) application does not establish a pathway for approval of follow-on products for biological products licensed under section 351 of the Public Heath Service Act, nor does it mean that more complex and/or less well understood proteins approved as drugs under the Food, Drug, and Cosmetic Act could be approved as follow-on products.

The majority of protein products are licensed as biological products under the Public Health Service Act, not approved as drugs under the Food, Drug, and Cosmetic Act. There is no abbreviated approval pathway analogous to 505(b)(2) or 505(j) of the Act for protein products licensed under section 351 of the Public Health Service Act. Such a pathway for the approval or licensure of follow-on protein products under the Public Health Service Act would require new legislation.

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