Generic Versions of Boniva Approved By the FDA

The U.S. Food and Drug Administration cleared the way yesterday for the first generic production of GlaxoSmithKline (NYSE:GSK) and Roche (PINK:RHHBY) osteoporosis treatment drug Boniva.

Apotex, Orchid Healthcare and Mylan Inc. (NASDAQ:MYL) have all been given approval from the FDA to market and sell the once-a-month 150 milligram (ibandronate) tablets. Generic drugs approved by the FDA have the same quality and strength as their brand-name equivalent, but may provide a lower cost to patients.

Boniva, endorsed in television advertisements by actress Sally Field, is one of the class of drugs used to treat the more than 40 million patients, both men and women, who suffer from osteoporosis.

Osteoporosis is a type of bone disease characterized by low bone mass and structural deterioration of bone tissue. The resulting problems associated with the disease include bone fragility and an increased risk of fractures of the hip, spine, and wrist, particularly during an accidental fall.

Boniva and the generic versions of its class of medications, called bisphosphonates, help increase bone mass, helping to reduce the chances of fractures.

“Men as well as women are affected by osteoporosis, a disease that can be prevented and treated,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “For people who must manage their health conditions over time, it is important to have affordable treatment options,” Webber said in an FDA press release.

Developed by GSK and Roche, Boniva was approved by the FDA for the treatment of postmenopausal osteoporosis in 2005. Boniva’s patent expired in Europe in 2011, and will expire in the U.S. at the end of March.

Boniva’s global sales reached $438 million in 2008, however those numbers have steadily declined, with sales in 2011 only reaching $105 million. Both figures are a small percentage of the estimated $6.8 billion osteoporosis treatment marketplace.

— Marc Bastow, InvestorPlace Assistant Editor

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