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Advair could face competition from generics as early as 2016 Posted 27/09/2013

GlaxoSmithKline’s (GSK) asthma and chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) could face competition from generics sooner than expected, after FDA issued draft guidance on generics of the drug.

On 9 September 2013, FDA issued draft guidance which would allow generics makers to submit in vitro and in vivo studies and simple bioequivalence trials to prove the drug works the same as Advair, rather than having to carry out long, expensive clinical trials.

Advair, which delivers two drugs to patients orally through an inhaler, is the world’s third best selling drug with revenue of GBP 5 billion (US$8 billion) last year and accounts for about a fifth of GSK’s annual sales. Only AbbVie’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab), biologicals which both treat arthritis, have greater worldwide sales.

Generics companies, including Actavis, Cipla, Mylan, Sandoz, Teva Pharmaceutical Industries and Vectura, are expected to launch generic versions of Advair as soon as 2016.

Until now, GSK and FDA had said that the same drug in a different inhaler was a different product because the device used to administer the medicine can cause dosing to vary. The vast majority of analysts had therefore assumed that ‘true’ generic versions of Advair were not likely to be launched in the US, due to the problem of dosing. While the patent on Advair expired in 2010 in the US, a separate patent on the Diskus device remains in force until 2016.

The draft guidance from FDA lays out the characteristics that an inhaler should have, including a similar size and shape to GSK’s Diskus device.

GSK told Bloomberg that they believed that ‘the manufacture of combination respiratory medicines such as Advair presents significant hurdles and remains extremely challenging.’

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Source: FDA

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