Making generics of Advair could be difficult

Generics/News | Posted 25/10/2013 post-comment0 Post your comment

GlaxoSmithKline’s (GSK) fears of generics competition for its chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) may be unfounded according to generics manufacturer Teva Pharmaceutical Industries (Teva).

Inhaler MD002004 V13J25

There had been speculation that GSK could face generics competition for its blockbuster drug Advair as soon as 2016. This came after FDA issued draft guidance on generics of the drug, saying that the agency would allow generics makers to submit in vitro and in vivo studies and simple bioequivalence trials to prove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 [1].

Generics giant Teva, however, does not expect to see the launch of generics of Advair that could be sold as a true substitute to US patients before 2018, according to its presentation on respiratory drugs. The company believes that producing a substitutable, or so-called AB-rated, version of Advair would still be challenging.

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) in 2012. Although the patents on the two active ingredients fluticasone and salmeterol have already expired, the patent on the delivery method (Diskus) does not expire until 2016. And even then GSK has said that ‘it would be difficult for generics firms to make an effective substitute’ for Advair.


1.  GaBI Online - Generics and Biosimilars Initiative. Advair could face competition from generics as early as 2016 []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 25]. Available from:

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Source: Teva

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