FDA approves first generics of Roche osteo drug Boniva

The US Food and Drug Administration yesterday approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly bisphosphonates product to treat or prevent osteoporosis in women after menopause, marketed by Roche (ROG: SIX).

Canada-based Apotex, India’s Orchid Healthcare and US firm Mylan Pharmaceuticals (Nasdaq: MYL) are the manufacturers that have gained FDA approval to market generic versions of ibandronate as 150mg ibandronate, which has been a blockbuster drug for the Swiss drugmaker. Generic versions can cost anywhere from 30% to 80% less than the original branded drug.

According to the National Institutes of Health, in the USA more than 40 million people either already have osteoporosis or are at high risk due to low bone mass. Roche’s sales of Boniva in the USA amounted to 313 million Swiss Francs ($341.7 million) in 2011, already down 30% year-on-year.