Seretide (salmeterol xinafoate/fluticasone propionate combination) - known as Advair in North America - is GSK’s lead respiratory product for asthma and chronic obstructive pulmonary disease (COPD). Last year the drug clocked in worldwide sales of £4.2bn ($6.4bn) and Mylan is looking to take a piece of the market reportedly worth £20bn through its generic.
Sirdupla is a pressurized metered-dose inhaler (pMDI) administering salmeterol/ fluticasone manufactured for Mylan by 3M Drug Delivery Systems at its plant in Loughborough. It has been made available in the UK today for adult asthma sufferers and Mylan’s Europe President Jacek Glinka said he is confident it will “broaden patient access” and ease the cost burden on the National Health Service (NHS).
Despite this, GSK spokesperson Claire Brough told in-Pharmatechnologist "entry of a salmeterol/fluticasone propionate copy has been anticipated in the UK for some time, especially given there has been no patent protection on this combination of active ingredients in the UK since 2004."
“Mylan’s Sirdupla is quite different from Seretide,” said a GSK spokesperson. “It is only approved for asthma – Seretide is approved for asthma and COPD. The copy is an MDI, and Seretide is approved in both an MDI and DPI (dry powder inhaler) inhaler format, [and] Seretide is also licensed for use in children with asthma from the age of 4 years and above [while] the new product is for 18 and over only."
"We will continue to work with health care providers in the UK to ensure that patients can start or continue to be treated on Seretide when their doctor or nurse or pharmacist believes that it is the most appropriate medicine for them," she added. "Seretide remains an important product in GSK’s respiratory portfolio."
Low generic penetration
There are generic versions of Seretide available in five other European countries and according to Abbas Hussain, Head of Global Pharmaceuticals at GSK, the firm is dealing well with these:
“Germany has had generics – and multiple generics – to Seretide since the middle of 2012,” he said at an investors event last month. “As of today, the penetration of those generics in Germany has been less than 4% in volume terms and we expect to continue to compete with Seretide generics in Europe.”
He added that while it is important to manage the decline of Advair but “it is also important to accelerate the growth of the new products [in GSK’s respiratory portfolio],” such as Breo - a combination of the inhaled corticosteroid fluticasone furoate (FF) and long-acting beta2-agonist (LABA) vilanterol.
In the US where last year sales of Advair (Seretide) were £1.9bn, there is no generic version and though the drug came off patent in 2010, the delivery device remains protected until 2016.
For GSK, it is the competition from alternative products in the asthma and COPD space, such as AstraZeneca’s Symbicort and Merck’s Singulair, which was responsible for a 29% y-o-y drop in US Advair sales in 2014.