Amgen is likely to receive FDA approval for denosumab, its newbiologic bone-loss drug, but it may be a hard sell against cheaper generics

Wall Street has set an exceptionally high bar for Amgen's new bone-loss treatment. Shares of the world's largest biotechnology company have jumped 30% since May, to 62, largely on news of clinical trials that showed the drug is at least as effective as standard osteoporosis treatments. At press time, an advisory board of the U.S. Food & Drug Administration was expected to recommend the agency approve the drug, known as denosumab.

At a time when the country is focused on reforming health care, however, some experts are asking an important question: Can the U.S. afford to protect the bones of millions of aging baby boomers? Mayo Clinic professor of medicine Dr. Sundeep Khosla isn't convinced Amgen's drug is that much better than older, more affordable alternatives, such as Merck's Fosamax, now available as a generic for as little as $100 a year. Amgen has not talked about pricing, but because denosumab is a biologic drug, it will likely cost more than even the priciest alternatives, such as Roche's Boniva and Novartis (NVS)'s Reclast, which cost up to $2,000 a year. "If there's only a marginal difference, you really need a reason not to use those older drugs," says Khosla.

BusinessWeek by Arlene Weintraub, 08/31/09

Tags: Endocrinology / Diabetes, osteoporosis