Generic Actos gains FDA approval
pharmafile | August 20, 2012 | News story | Sales and Marketing | Actos, Mylan, Ranbaxy, Takeda, diabetes, generic
Takeda’s big-selling diabetes pill Actos will have its US sales decimated after the FDA approves three copycat versions of the drug.
Ranbaxy, Teva and Mylan have been given ‘first-to-file’ rights in the US to sell generic forms of the drug for the next six months. After this period, any other generic firm can apply to sell copies of Actos.
Watson Pharmaceuticals had also filed to sell a generic version of Actos, but was denied shared exclusivity with Ranbaxy, Teva and Mylan by the FDA – the firm says it is now planning to sue the regulator over its decision.
Actos has become one of the world’s biggest-selling diabetes treatments, and brought in $2.7 billion in the US last year according to IMS Health.
But this will now be decimated by generics, which usually sell at around 70 – 90% below the price of their branded rivals.
Actos (pioglitazone) works by helping type II diabetes improve their blood glucose levels and is in the same groups of medicines as GSK’s Avandia.
Avandia was pulled of the European market in 2010 after studies showed that the drug increased the risk of serious cardiovascular events – the FDA however only limited its use and added further safety warnings.
Actos also has a ‘Boxed Warning’ from the FDA warning that it can cause or worsen heart failure, particularly in certain patient populations – it has also been show to slightly increase the risk of bladder cancer, but regulators were not inclined take it off the market.
“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” said Gregory Geba, director of the office of generic drugs at the FDA.
“Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”
Mylan’s chief executive Heather Bresch, added: “Mylan’s immediate launch of these products is representative of the company’s ongoing commitment to expand access to high quality, more affordable medicines.
“A crucial part of setting new standards in health care includes meeting patients’ unmet needs, and we look forward to continuing to grow our portfolio of products for patients living with diabetes.”
Ben Adams
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