FDA guidance on generic Advair

Bloomberg reports that the FDA has revised guidelines for generic competitors of prescribed drugs to introduce copies on the market by stating that long and expensive human tests are not required to show drugs work the same as, forinstance, Advair ( salmeterol + fluticasone).

Advair, an inhaled medicine for Asthma and Chronic Obstructive Pulmonary Disease, is the world�s third-best selling drug with revenue of �5.05 billion ($7.95 billion) in 2012 and accounts for about 20 percent of Glaxo�s annual sales.

Glaxo, and until now the FDA, have said that the same drug in a different inhaler is a different product because the device used to administer the medicine can cause dosing to vary. While the patent on Advair expired in 2010 in the U.S., a separate patent on the Diskus device remains in force through 2016. The FDA�s guidance described the characteristics that an inhaler should have, including a similar size and shape to Diskus. Those guidelines will rule out some generic devices, and suggest that those developed by Vectura Group Plc and Orion Oyj will qualify. A generic may reach the market in late 2014 or in 2015.