Hospira sees generic EPO in U.S. in 2012

By Susan Kelly

NEW YORK (Reuters) - Hospira Inc (HSP.N: Quote, Profile, Research, Stock Buzz) hopes to launch a generic anemia drug in the United States in 2012 and sees legislation laying the groundwork for generic biologics passing next year, the company's chief executive said Tuesday.

Proponents of generic biologics say the products could help curb skyrocketing health care costs; but biotech drug makers argue that the medicines, which are derived from living cells, are more complex than chemical compounds and difficult to copy.

Hospira, the world's largest maker of generic injectable drugs, is aiming to launch a generic version of anemia biologics called erythropoiesis-stimulating agents, or EPO drugs, which millions of cancer and kidney disease patients now take.

"The interest level is extremely high," Hospira Chief Executive Chris Begley said at the Reuters Health Summit in New York. "We now realize it's the right thing to do, to help keep health care costs down."

Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) makes the anti-anemia drugs Epogen and Aranesp and Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz) makes Procrit.

Hospira's generic biologic, called Retacrit, could be on the U.S. market as soon as 2012, when patents for branded EPOs begin to expire, Begley said.

European regulators last month cleared the way for Hospira to launch the product, its first biogeneric, in European Union countries in early 2008. Lake Forest, Illinois-based Hospira is in the process of hiring a sales staff of about 100 people to market the drug to physicians overseas, Begley said.

Cost savings for generic EPOs are likely in the 20 percent to 25 percent range compared with the branded drugs, he said.

Congress is considering legislation that would give the U.S. Food and Drug Administration legal authority to approve alternative versions of biologic drugs in the United States after patents expire.

While some analysts see passage of a bill as unlikely next year, Begley is more optimistic, citing an urgency to get clinical studies under way. "I believe in 2008 some sort of legislation will get passed," he said.

Going forward, the industry's development of generic biologics, also called biosimilars, will focus insulin, human growth hormone and alternative versions of TNF inhibitors to treat rheumatoid arthritis, in addition to cancer drugs, Begley said.

Hospira has six biosimilars in development, some in the cancer category, Begley said, but he declined to provide specific details on products in the pipeline.

Begley gave financial goals for Hospira, which also makes medicine delivery pumps, for