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[Biowatch]

FDA approves hormone in generic biotech debate
Sandoz says first follow-on drug to get nod; FDA says not precedent setting

By Steve Goldstein, MarketWatch
Last Update: 5:33 AM ET May 31, 2006

LONDON (MarketWatch) -- The U.S. Food and Drug Administration has approved Novartis AG's Omnitrope hormone, possibly setting a precedent that could allow for clones of biotechnology drugs.
The Sandoz unit of Novartis (NVS ) said on Wednesday the ruling in favor of Omnitrope, used to treat growth disorders in children and adults, is precedent setting and is the first follow-on version of a previously approved recombinant biotechnology drug.

A recombinant biotechnology drug is one grown in living cell lines, as opposed to a manufactured chemical.

Novartis shares were little moved in Swiss trading.

"The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the U.S," said Andreas Rummelt, chief executive of Sandoz.

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

"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 FDA said. See external link to FDA Q&A.
http://www.fda.gov/cder/drug/infopage/somatropin/qa.htm

"Biologics raise unique concerns due to the close relationship between the product's manufacturing process and its clinical attributes," the agency said in a letter to the Pharmaceutical Research and Manufacturers of America trade association.

The FDA and Sandoz have been at odds for years over the issue, with Sandoz suing -- and winning in April -- a case over the agency's refusal to act on the application.

Omnitrope, which is similar in composition to Pfizer's (PFE ) Genotropin, was approved by the European Commission in April.

Steve Goldstein is MarketWatch's London bureau chief.