U.S. copy of GSK's Advair a step closer as Mylan files generic version

LONDON, Jan 12 (Reuters) - The arrival of cheap generic versions of GlaxoSmithKline (Other OTC: GLAXF - news) 's top-selling lung drug Advair has moved a step closer with confirmation from Mylan (Tel Aviv: 27249935.TA - news) that it has submitted a generic version for approval.

Mylan said late on Monday it had filed an abbreviated new drug application to the U.S (Other OTC: UBGXF - news) . 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 crystallised 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.

Novartis (LSE: 0QLR.L - news) ' 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 (NYSE: AZN - news) 's Symbicort. ($1 = 0.6882 pounds) (Reporting by Ben Hirschler; Editing by Susan Fenton)