Novartis gives up trying to copy Advair

One of the most surprising nuggets of information in Novartis’s full-year financials today was the revelation that its Sandoz division had canned development of a generic version of Glaxosmithkline’s Advair. The Swiss group had widely been expected to refile imminently, having carried out additional work in response to a US complete response letter. But today is said it could no longer see a pathway to launch in the next 18 months, adding that the decision was “data-driven” rather than regulatory. On the face of it this is good news for Hikma/Vectura, whose rival generic has also been derailed by a CRL, though more realistically it underlines just how tough it will be for anyone to get an approval. Teva’s Advair competitor is non-substitutable, and the only true generics to get US FDA approval are from Mylan – also after a lengthy delay – and an authorised product from Prasco Laboratories. Any erosion to branded Advair’s US sales looks to be gradual.