Mylan discloses FDA filing for generic version of GlaxoSmithKline's Advair Diskus

Mylan announced the filing of an application with the FDA in December seeking approval for a generic version of GlaxoSmithKline's Advair Diskus (fluticasone/salmeterol). The inhaled therapy is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Analysts suggest that if Mylan's drug is approved under a standard review period, then a generic version of Advair that may be routinely substituted for GlaxoSmithKline's therapy could be launched in 2017. Last year, GlaxoSmithKline CEO Andrew Witty acknowledged that the company is preparing for the arrival of generic competition to Advair in the US, although he noted that the likelihood of this occurring in 2016 was "vanishingly small."

GlaxoSmithKline's long-term guidance forecasts that US sales of Advair could drop to less than 300 million pounds ($433 million) in 2020, down from 2 billion pounds ($2.9 billion) in 2014. However, Jefferies analysts said Mylan's announcement had crystallised this key threat. "Whilst already partially factored into longer-term expectations, this is not reflected in mid-term consensus and represents downside risk, putting further pressure on management in a key recovery year," the analysts said.

For related analysis, read ViewPoints: More promises, but it's time for GlaxoSmithKline to deliver, and for more information on the US asthma and COPD market, see Market Access Impact: Asthma/COPD (US).

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