[Ip-health] Is the FDA Set to Bring On Generic Biologics?

[Mike Palmedo]

http://www.patentbaristas.com/archives/000407.php

Is the FDA Set To Bring On Generic Biologics?

PatentBaristas.com
May 31, 2006

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=92s 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.