FDA approves generic copies of Roche’s Boniva

The US Food and Drug Administration (FDA) have approved three generic versions of Roche's osteoporosis medication Boniva.

Copies of the once-monthly, 150mg tablets, produced by Mylan, Apotex and Orchid Chemicals & Pharmaceuticals, can now be marketed towards sufferers of the bone condition.

US FDA Centre for Drug Evaluation and Research Office of Pharmaceutical Science deputy director Keith Webber heralded the arrival of generic treatments for the disease.

"For people who must manage their health conditions over time, it is important to have affordable treatment options," added Webber.

Osteoporosis is the most common type of bone disease, affecting more than 40 million people in the US, and leads to bone fragility and an increased risk of bone fractures due to low bone mass and bone tissue deterioration.

Boniva, belonging to the bisphosphonate class of drugs, directly competes with other bisphosphonates including Novartis' Reclast/Aclasta/Zometa and Merck & Co's Fosamax for a target group estimated to be around 5 million people in the US alone.

Sales of Boniva are now widely predicted to take a further fall, following on from a 31.3% decrease recorded in 2011.FDA approves generic copies of Roche’s Boniva - Pharmaceutical Technology