Hikma Pharmaceuticals (LON:HIK) disclosed today that the FDA decided not to approve its version of the inhaled asthma treatment, due to “major” problems with the application. This comes on the heels of Mylan‘s (NSDQ:MYL) announcement in March that the federal watchdog delayed approval of its Advair generic.
Thanks to these 2 rejections, industry analysts believe that the threat of generic competition has been pushed back until next year, according to Reuters.
Both Hikma and Mylan received complete response letters from the FDA that were categorized as major. A major amendment to a generic drug application comes with a delay of 10 months for an updated FDA response.
Hikma said it was reviewing the FDA’s response. Yesterday, Mylan said it disagreed with the reasoning behind the agency’s decision. The company said the FDA was asking Mylan to comply with draft guidance, rather than rules that the 2 parties previously agreed upon.
The threat of an Advair competitor is the 1st big challenge for GSK’s new chief executive, Emma Walmsley. Although the company has a number of new respiratory drugs, any generic competition will likely hit profits, since the drug generates high margins.
GSK said that without a generic competitor for Advair in the U.S. this year, it expects adjusted earnings per share to rise by 5-7% in 2017.
Last year, Advair brought in $2.37 billion in sales in the U.S.
Material from Reuters was used in this report.