Mylan debuts generic Seretide in UK

Mylan has become the first company to launch a generic version of GlaxoSmithKline's (GSK) big-selling respiratory drug Seretide in the UK.

Seretide (salmeterol xinafoate/fluticasone propionate) – sold as Advair in the US and other markets – is the top-selling inhaled beta agonist and corticosteroid combination therapy in the UK. The drug is GSK's biggest product, pulling in around £900 million in the first quarter of the year.

Mylan is launching its generic under the Sirdupla brand name and in a pressurised metered dose inhaler (pMDI) device developed by 3M. Like its branded rival, the new product is approved to help treat or prevent symptoms of asthma in adults 18 years of age and older.

Mylan notes that the UK has one of the highest rates of asthma in Europe, affecting one in five households, and the disease kills three people in the country every day.

There are 5.4 million people suffering from asthma in the UK, it adds, and the condition costs the National Health Service (NHS) £1 billion ($1.53 billion) a year.

Mylan's president Rajiv Malik said the launch of Sirdulpla would "broaden patient access to an important treatment option" and also gave UK patients a "familiar pMDI device experience."

He also said the availability of a generic would help to reduce the burden of asthma on the NHS. However, Seretide is available both as a pMDI and in the Diskus dry powder inhaler, and is also approved for patients with chronic obstructive pulmonary disease (COPD) as well as asthma in children, so Mylan is only competing in a segment of the current Seretide market.

For GSK, the arrival of generic Seretide in the UK puts additional pressure on the brand, which is already suffering as a result of generic competition in other European markets as well as sustained, downward pricing pressure in the US and EU.

GSK has been trying to defend its franchise with the launch of new products such as Seretide follow-up Breo (vilanterol/fluticasone furoate) and a muscarinic antagonist/beta agonist combination called Anoro (vilanterol/ umeclidinium), but these have so far failed to generate much momentum.

Breo brought in £41 million in the first three months of the year, while Anoro added another £12 million, unable to offset the approximately £100 million reduction in Seretide/Advair sales in the quarter.

GSK has said it does not believe generic competition to Advair will arrive in the US this year, but has conceded it is a possibility, and this would place another £1.5 million-worth of sales at risk. Mylan indicated in its first-quarter results announcement that it would file for generic Advair before the end of the year.