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First Advair generic launched in the US Posted 05/05/2017

Teva Pharmaceutical Industries (Teva) has announced the launch of AirDuo RespiClick and its authorized generic, the first competitor to GlaxoSmithKline's (GSK) best-selling asthma drug Advair in the US.

Advair, a combination of the anti-inflammatory fluticasone and long-acting beta-adrenergic agonist (LABA) salmeterol, is used to treat asthma and chronic obstructive pulmonary disease (COPD). The combination drug helps to prevent coughing and shortness of breath and was launched in the US by GSK in 2001.

Patent protection on the drug expired in 2010 and in 2013, the US Food and Drug Administration (FDA) issued guidance which would allow generics manufacturers to submit in vitro and in vivo studies and simple bioequivalence trials [1], leading to suggestions that a generic drug version could be just around the corner. However, generic drug manufacture turned out to be more difficult than originally thought, partly due to the lack of an FDA standard for the bioequivalence of inhaled steroids in multi-dose or dry powder inhalers and an intact patent on the delivery method. Teva commented that ‘it would be difficult for generics firms to make an effective substitute’ [2].

Despite earlier claims, in April 2017 Teva announced the launch of two direct competitors to Advair:

  • AirDuo RespiClick(fluticasone propionate and salmeterol) inhalation powder, which will cost (wholesalers or direct purchasers) US$285
  • A generic version, authorized for the treatment of asthma in patients aged 12 and above who are uncontrolled on an inhaled corticosteroid (ICS), or whose disease warrants the use of an ICS/LABA combination. The generic drug will cost less than half of the branded version, at just US$90. This is around 70–80% cheaper than Advair

AirDuo RespiClick was approved by FDA earlier in 2017, in three different doses, to be administered as one inhalation twice per day. The active ingredients are delivered by Teva’s RespiClick breath-activated, dry powder inhaler. GSK’s delivery method is called Diskus, the patent on which expired in 2016.

Teva will launch the products simultaneously to make asthma treatment options in the US more affordable, predicting that the generic version will contribute the most sales. The company commented that it hopes to increase patient access to inhaler technology.

The product launch represents the first generic Advair in the US. This will be disappointing news for GSK. Advair is a top-selling drug, bringing in sales of US$2.35 billion in 2016 alone. However, a GSK representative commented that neither of the products are ‘therapeutically equivalent or substitutable’ for Advair. Indeed, Teva’s versions contain less salmeterol than Advair and have not been approved for use in COPD.

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1. GaBI Online - Generics and Biosimilars Initiative. Advair could face competition from generics as early as 2016 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 2]. Available from: www.gabionline.net/Generics/News/Advair-could-face-competition-from-generics-as-early-as-2016

2. GaBI Online - Generics and Biosimilars Initiative. Making generics of Advair could be difficult. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 2]. Available from: www.gabionline.net/Generics/News/Making-generics-of-Advair-could-be-difficult

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Source: Teva, US FDA

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