LONDON, Jan 12 (Reuters) - The arrival of cheap genericversions of GlaxoSmithKline's top-selling lung drugAdvair has moved a step closer with confirmation from Mylan that it has submitted a generic version for approval.
Mylan said late on Monday it had filed an abbreviated newdrug application to the U.S. Food and Drug Administration inDecember.
If its product is approved under a standard review period, ageneric version of Advair that may be routinely substituted forGSK's medicine could be launched in 2017, analysts believe.
That should not come as a huge surprise to investors, sinceGSK's own long-term guidance already assumes U.S. Advair salescould fall to 300 million pounds ($435 million) in 2020, from1.97 billion in 2014, if substitutable generics are launched.
But Jefferies analysts said Mylan's announcement hadcrystallised this key threat at a time when GSK is looking for arecovery in 2016.
"Whilst already partially factored into longer-termexpectations, this is not reflected in mid-term consensus andrepresents downside risk, putting further pressure on managementin a key recovery year," they said in a research note.
GSK shares were little changed in early trading on Tuesday.
Novartis' Sandoz unit is also working on a genericcopy of Advair and the arrival of such cut-price versions islikely to add to price pressures across the respiratory market,affecting similar products such as AstraZeneca's Symbicort. ($1 = 0.6882 pounds) (Reporting by Ben Hirschler; Editing by Susan Fenton)
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Glaxosmithkline (GSK)
