Mylan’s Advair generic approval hinges on solidity in meeting FDA guidelines; true equivalence a hurdle – experts

31 Jan 2017

Mylan's (NASDAQ: MYL) bid for approval of MGR001—generic of GlaxoSmithKline’s (LON:GSK) Advair (fluticasone/salmeterol) inhaler—is within reach but dependent on the data-package’s precision to specific FDA guidelines introduced in 2013, said experts.

Irrespective of concerns raised by Novartis’ (VTX:NOVN) Sandoz in a citizen petition to delay any ANDA approvals for Advair generics, experts said an approval will likely be based on FDA’s guidance. Additionally, some experts said while the guideline-mandated lung function tests may not be the best measure for equivalence between a generic and originator, it is unlikely to cause any issues since the FDA itself had mandated them. Experts also flagged Mylan’s lack of data in adolescents – in line with the FDA guidance and Advair label– which could potentially impact the review and label.

While Sandoz’s inter-batch variability concerns may be important, experts said in the absence of large scale studies to suitably address this challenge, and the presence of peripheral factors that affect dose-dose variability, it is unlikely to stop or delay an approval.

Total US Advair annual sales in 2015 were GBP 1.86bn and 1H16 sales were GBP 826m. Mylan has a GDUFA date of 27 March for an FDA decision on the approval of MGR001, and has not yet released preclinical or clinical MGR001 data. Advair went off-patent in 2010. Analysts have been reserved on Mylan’s approval chances due to the absence of any approved Advair generic and potential FDA hurdles.

Advair is approved for chronic obstructive pulmonary disease (COPD) at the 250mg/50mcg dose, while it is approved at the 100/50 mcg dose for treating asthma patients between 4 and 11 years of age. Additionally, Hikma (LON:HIK) and Sandoz have also been in touch with the FDA about their own generic versions of Advair.

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