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 Mylan said late on Monday it had filed an abbreviated new drug
application to the U.S. Food and Drug Administration in December.
If its product is approved under a standard review period, a generic
version of Advair that may be routinely substituted for GSK's
medicine could be launched in 2017, analysts believe.
That should not come as a huge surprise to investors, since GSK's
own long-term guidance already assumes U.S. Advair sales could fall
to 300 million pounds ($435 million) in 2020, from 1.97 billion in
2014, if substitutable generics are launched.
But Jefferies analysts said Mylan's announcement had crystallized
this key threat at a time when GSK is looking for a recovery in
2016.
"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," they said in a research note.
GSK shares were little changed in early trading on Tuesday.
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Novartis' Sandoz unit is also working on a generic copy of Advair
and the arrival of such cut-price versions is likely to add to price
pressures across the respiratory market, affecting similar products
such as AstraZeneca's Symbicort.
(Reporting by Ben Hirschler; Editing by Susan Fenton)
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