FDA finally approves Mylan's Advair generic


The FDA has finally approved the first generic of GlaxoSmithKline’s Advair blockbuster respiratory diseases inhaler, after years of delays.

Even though Advair’s main patent expired in 2010 and the patent on the Diskus inhaler expired in 2016, until now no-one has managed to get the FDA to approve a cheaper copy of the drug-device combination.

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

However the regulator said at the time that there were only “minor deficiencies” in Mylan’s filing and it always looked likely that the generics and biosimilars firm would get it right the second time around.

Sandoz said this week that it 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.

Approved in asthma and chronic obstructive pulmonary disease (COPD), Advair is a combination of the long-acting beta agonist salmeterol and the corticosteroid fluticasone and is still a blockbuster, generating US sales of £308 million in Q3.

Even though this is well off its peak, the drug is still GSK’s second best selling drug and none of its more recently approved respiratory drugs can match it for sales.

Approval of Mylan’s generic, in patients aged four years and older with asthma, and airflow maintenance and prevention of exacerbations in COPD,  will therefore put more pressure on GSK’s respiratory drug franchise.

The generic will not be indicated for relief of acute bronchospasm.

Mylan obtained approval to market the generic dubbed Wixela Inhub in three strengths: fluticasone propionate 100 mcg/salmeterol 50 mcg, fluticasone propionate 250 mcg/salmeterol 50 mcg and fluticasone propionate 500 mcg/salmeterol 50 mcg.

The company plans to launch the drug in the second half of February incorporating the latest safety information required by the FDA earlier this month, which prompted an amendment to the label for certain inhaled corticosteroids, including Advair and generics.

The approval will also be a victory for those who are concerned about the high cost of branded medicines in the US – many patients will pay all or some of these treatments from their own wages, potentially limiting access if they cannot cover the cost.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said: “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today's approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

In Europe, where the originator drug is branded as Seretide, generics have been on the market for several years.