Mylan launches Advair generic at 70% discount in US

Mylan has launched its generic version of GlaxoSmithKline’s respiratory blockbuster, Advair, at a 70% discount compared with the original drug.

Cheaper competition to off-patent Advair has been delayed for years in the US as generic firms struggled to overcome the FDA’s stringent approach to copies of drug-device combination products.

The main patent on Advair (fluticasone+salmeterol) expired as long ago as 2010, while the patent on GSK’s Diskus inhaler expired in 2016.

But Mylan became the first of a group of potential competitors to get generics approved last month, and has followed this with a keenly-priced launch.

GSK said in its fourth quarter results briefing last week that it expects profits to be down by around £800 million this year as a result of the generic competition.

All three strengths of the competitor branded as Wixela Inhub will be offered at a wholesale cost of 70% less than Advair Diskus and 67% less than GSK’s authorised generic version, which launched last week.

The wholesale acquisition costs of Wixela Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths are $93.71, $116.44 and $153.14, respectively.

However Mylan noted that the wholesale price does not necessarily reflect that paid by consumers, pharmacies, or third-party payers.

Mylan will also offer patient services to provide training and education about the treatment and device.

Wixela Inhub is indicated for the twice daily treatment of asthma in patients age four and older not adequately controlled on long-term asthma medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists.

It is also approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm.

Mylan’s chief commercial officer Tony Mauro said the company had “numerous discussions” with customers about its launch strategy.

He added: “We trust that by launching Wixela Inhub at a significantly discounted list price, we will demonstrate the savings that generics can deliver for patients through reduced out-of-pocket costs, as well as the US healthcare system overall.”

Novartis’ Sandoz generics arm, and Hikma have tried unsuccessfully to get copies approved, and the regulator had rejectedMylan’s generic last summer.

Sandoz does not expect to launch its version until next year, and Hikma and partner Vectura require a further trial to get their drug past the FDA.