Mylan submitted its own ANDA for a generic version of Advair, and after rejection, they received a complete response letter from FDA in March 2017. This came not long after a petition was submitted to FDA by rival company Sandoz [1]. In this they requested that FDA not to approve any ANDAs that do not control error rates in BE testing and account for batch-to-batch variability, or ensure that the PK testing is sensitive enough to product differences. Here, they specifically challenged the draft guidance recommendations for fluticasone propionate/salmeterol xinafoate inhalers on the grounds that Advair Diskus 100/50 batch-to-batch variability is not taken into consideration.

In Mylan’s current petition, they note that Sandoz’s own generic version of Advair Diskus is unable to establish BE for the 100/50 strength using the methods laid out in the guidance. Here, Sandoz proposes a multiple-batch approach for that strength. Sandoz’s ANDA for a generic version of Advair was accepted by FDA in June 2016.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Sandoz petitions FDA over requirements for generics of Advair Diskus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. Available from: www.gabionline.net/Generics/General/Sandoz-petitions-FDA-over-requirements-for-generics-of-Advair-Diskus

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