Advair generic setback sends shares in GSK upwards

A day after announcing that its  2018 outlook was dependent on the timing of generic competition to its blockbuster Advair/Seretide (salmeterol/fluticasone) lung drug, UK pharma major GlaxoSmithKline (LSE: GSK) received a major boost relating to that very issue.

The US Food and Drug Administration (FDA) has sent a complete response letter (CRL) to Sandoz, the generics unit of Novartis (NOVN: VX), in relation to its copy of Advair, and its contents have led the Swiss pharma giant to accept that it is unlikely to launch a competitor this year.

With Mylan (Nasdaq: MYL)  also receiving a CRL on its application for an Advair copy in March 2017 and Jordan-based Hikma Pharmaceuticals (LSE: HIK)  getting one too a couple of months later, the US competition that was feared last year did not materialize and now there are questions over whether a generic version will enter the market in 2018.