- Mylan has launched the first generic to GlaxoSmithKline's Advair Diskus at a significant discount to the branded version, the generic drugmaker announced Tuesday, increasing the potential for the copycat drug to steal significant market share.
- Marketed as Wixela Inhub, the generic will carry a wholesale acquisition cost (WAC) that's 70% lower than Advair's and 67% below that of GSK's authorized generic, which launched on Feb. 8.
- Like Advair, Wixela Inhub is a fixed dose combination of fluticasone and salmeterol. Both drugs are approved for treatment of asthma in children and adults, maintenance treatment of COPD, and reduction of COPD exacerbations.
After a series of setbacks, Mylan finally secured Food and Drug Administration approval for its copycat last month.
Its launch brings competition to GlaxoSmithKline's blockbuster Advair franchise, which remains a multi-billion dollar business despite slowing sales.
In marketing Wixela Inhub, Mylan will have the advantage of being first to market, as copies developed by Novartis and the team of Vectura and Hikma Pharmaceuticals remain some distance from approval.
"The low WAC price point reflects the reality of first-to-market, limited competition launches on large dollar volume drugs where competition is both against an authorized generic equivalent as well as hefty rebate dollars on the branded asset," wrote Elliot Wilbur, an analyst at Raymond James, in a note to investors.
Wilbur estimates a generic market value of $600 million to $650 million, with Mylan set to capture a third or more of that market for potential revenues between $250 million to $300 million.
GSK has prepared for the generic's launch, and expects some of its newer respiratory brands will make up for the expected shortfall. Advair sales fell by 30% over the course of 2018 and further declines are predicted this year.
On a recent conference call, GSK's Chief Financial Officer Simon Dingemans noted in particular the potential of the company's Ellipta portfolio and Nucala (mepolizumab).
The pharma doesn't foresee the Advair generic to have an impact on sales of its other respiratory products.