advair23 Mar 2017 21:20
ADVAIR CHALLENGE FOR GSK
The picture is a lot less certain for Britain's GSK as it faces the threat of cut-price competition from Mylan, which hopes to secure approval for the first substitutable generic copy of GSK's top-selling Advair lung drug by March 28.
Mylan believes it has done everything required to win FDA approval but its version of Advair would be the first complex inhaled combination generic product to be approved by the U.S. agency, so nothing is guaranteed.
That complexity has led some analysts to question whether Mylan will succeed at its first attempt to gain approval, potentially delaying the arrival of generics and shielding GSK's profits from immediate attack.
A second generic version of Advair from Hikma Pharmaceuticals and Vectura is also awaiting an FDA approval decision by May 10.
Dealing with the threat of competition to Advair, which has generated more than $1 billion in annual sales since 2001, is the first big challenge facing GSK's new chief executive, Emma Walmsley, who takes over at the end of this month.
GSK has told the market that core earnings per share, in constant currencies, will be flat to slightly lower in 2017, if substitutable Advair generics arrive in the United States by mid-year. If they don't launch, EPS should rise between 5 and 7 percent. (Editing by Greg Mahlich)