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.
Advair and its generics | |||
---|---|---|---|
Company | US status | Note | Global 2019e sales |
Glaxosmithkline | Available since 2001 | Original brand | $2,232m |
Teva | Airduo Respiclick approved Jan 2017 | Not substitutable | $12m |
Mylan | Wixela Inhub approved Jan 2019, after Mar 2017 CRL | Substitutable | $441m |
Prasco Laboratories | Launched Feb 2019 | Authorised generic | NA |
Hikma/Vectura | CRL May 2017; upheld in Mar 2018 | New study requested, Hikma responded Nov 2019 | None |
Sandoz (Novartis) | Discontinued after Feb 2018 CRL | Had been aiming to refile in 2019 | None |
Source: company releases & EvaluatePharma. |