After Hikma and Mylan fail, Sandoz files Advair generic in US

GlaxoSmithKline’s ageing respiratory blockbuster Advair has been living a charmed life since going off patent years ago - but as yet no-one has been able to get a generic rival approved in the key US market.

Only this year, the FDA rejected generics of Advair (fluticasone+salmeterol) from Hikma and Mylan – but it looks like Sandoz could succeed where its rivals have failed.

Novartis’ generics division said the regulator has accepted Sandoz’s filing for a generic of Advair Diskus, known as Seretide in Europe.

If approved, the product will treat asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The FDA had “major” issues with filings from Hikma and Mylan, suggesting these generics could be delayed until mid-2018.

Approved in asthma and COPD, Advair is still bringing in around £750 million every quarter, with around 45% of those sales based in the US.

GSK’s new CEO Emma Walmsley has said that earnings will grow this year without a US generic competitor to Advair, with flat or slightly declining earnings per share should a rival make to market.

Peter Goldschmidt, president of Sandoz's US division, said: “We know the treatment of asthma and COPD place a significant cost burden on patients and the healthcare system in the US. We are confident in our application and data, and we look forward to working with the FDA to provide greater access and affordability for this treatment option."

Sandoz developed the product through its acquisition of Oriel Therapeutics back in 2010 – the same year that the Seretide US patent expired.

The acquisition gave Sandoz access to the Advair generic plus a portfolio of other respiratory generic medicines, plus a novel drug delivery system and a dry powder inhaler.