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Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies Posted 19/01/2018

On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbreviated new drug applications (ANDAs) for generic versions of Advair Diskus that rely on data from multiple-batch studies to demonstrate pharmacokinetic (PK) bioequivalence (BE). The agency’s guidance on evaluating generic bioequivalence for this Glaxo Smith Kline asthma drug, specifies a single-batch trial design and Mylan is requesting that this is adhered to. 

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 Here, they specifically challenged the draft guidance recommendations for fluticasone propionate/salmeterol xinafoate inhalers on the grounds that Advair Diskus 100/50 batch-to-batch variability is not taken into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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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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Source: Mylan

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