June 1, 2006

After a nearly three-year delay, the FDA has approved Sandoz's generic human growth hormone Omnitrope -- the first follow-on biologic approved under the 505(b)(2) statute of the Federal Food, Drug and Cosmetic Act (FDCA).

The approval comes after a federal court -- in response to a lawsuit filed by Sandoz -- ordered the FDA to issue a decision on Omnitrope (somatropin rdna origin), calling the agency's nearly 1,000-day review "unreasonable." Omnitrope has already been approved for use in the European Union and was launched in Australia in 2005.

The agency said it believes it has the authority to develop a regulatory path for follow-on protein products approved under Section 505 of the FDCA, but emphasized that its approval of Omnitrope does not create a new pathway for approval of follow-on versions of all biologics. Most biologic products are regulated under Section 351 of the Public Health Service Act, but human growth hormone products have historically been regulated under Section 505.

"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 Health 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 FDA said in a question-and-answer sheet issued after the May 30 approval. "A pathway for approval or licensure of follow-on protein products under the Public Health Service Act would require new legislation."

Biotech companies have asserted that biologic drugs are too complex to reverse-engineer, but generics makers say they have the science to do it.

In a statement, Kathleen Jaeger, president of the Generic Pharmaceutical Association, said, "Although it is our position that the 505(b)(2) FDCA approval process, in conjunction with FDA's authority under the Public Health Act (PHS), already serves as a foundation for the approval of safe and effective generic biopharmaceuticals, we will continue to call on Congress to codify FDA's authority to approve generic biopharmaceuticals under section 351 of PHS." (http://www.fdanews.com/did/5_107/)