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.

Mylan received approval from the US Food and Drug Administration (FDA) on 30 January 2019 as the first substitutable generic of Advair Diskus. FDA said the approval was part of the agency’s longstanding commitment to advance access to lower cost, high quality generic alternatives.

Patent protection on the drug expired in 2010 and in 2013, 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.

An authorized generic of Advair has been on the market in the US since Teva Pharmaceutical Industries launched its product in May 2017 [1]. However, generics makers have found it difficult to produce substitutable generics of Advair, partly due to the lack of an FDA standard for the bioequivalence of inhaled steroids in multi-dose or dry powder inhalers and a patent on the delivery method that lasted until 2016 [2].

Wholesale costs for Wixela Inhub at dosages of 100 µg/50 µg, 250 µg/50 µg and 500 µg/50 µg strengths are US$93.71, US$116.44 and US$153.14, respectively. These prices make Wixela Inhub 70% less than Advair Diskus and 67% less than GSK’s authorized generic which was launched on 8 February 2019. Mylan did point out, however, that the wholesale price does not necessarily reflect the price paid by consumers, pharmacies or third-party payers.

Mylan says that it will also offer patient services to provide training and education about the treatment and device.

Related articles
Sandoz petitions FDA over requirements for generics of Advair Diskus

Making generics of Advair could be difficult

References
1. GaBI Online - Generics and Biosimilars Initiative. First Advair generic launched in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Generics/News/First-Advair-generic-launched-in-the-US
2. 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 2019 Mar 1]. www.gabionline.net/Generics/News/Advair-could-face-competition-from-generics-as-early-as-2016

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.