D-Day has finally come for Glaxosmithkline with US approval of Mylan’s generic version of Advair. The UK company has been preparing for this for some time – indeed, it is fortunate to have escaped copycats for this long. But the rewards for generics developers now look less attractive than before. Glaxo has been aggressively discounting Advair and seeking to lock in contracts with Medicare Part D plans, worth 40% of the market, the Evercore ISI analyst Umer Raffat noted. He estimated that Mylan’s Wixela Inhub could bring in $250m in 2019, based on it gaining a majority share of the non-Part D segment and being priced at a 25% discount to Advair. At least Mylan has crossed the finish line; Novartis and Hikma have been delayed, and their versions do not look likely to hit the market until 2020. Teva already has an approved product, but this is not directly substitutable and has struggled to gain traction. In the absence of generic competition US Advair sales have already more than halved since 2013, and in 2018 were expected to have fallen 30% year on year. More guidance might be available when Glaxo reports results next week.
|US generic versions of Advair|
|Teva||Airduo Respiclick approved Jan 2017||Not substitutable|
|Mylan||Wixela Inhub approved Jan 2019||Substitutable|
|Hikma/Vectura||CRL May 2017; upheld in Mar 2018||New study requested, Hikma to respond in 2019|
|Sandoz (Novartis)||CRL Feb 2018||Aiming to refile in 2019 as per Q4 results call|
|Source: company releases.|