In October 2014, Mylan will commence a phase III clinical trial to evaluate the equivalence of its product to GlaxoSmithKline’s (GSK’s) Advair Diskus (fluticasone/salmeterol) when administered by inhalation in adult asthma patients. Advair delivers two drugs to patients orally through an inhaler, and is the world’s third-best selling drug with revenue of GBP 5 billion (US$8 billion) in 2012 [1].

Although the patents on the two active ingredients fluticasone and salmeterol have already expired, the patent on the delivery method (Diskus) does not expire until 2016. Brand-name manufacturer GSK and generics giant Teva Pharmaceutical Industries have both said that making a substitutable, or so-called AB-rated, version of Advair would be challenging [1].

Mylan also joins a growing number of companies working on biosimilar insulin [2]. Two phase III clinical trials for Mylan’s insulin analogue programme are already underway. In August 2014, the company initiated INSTRIDE 1 and INSTRIDE 2 to compare the efficacy and safety of Mylan’s insulin glargine with that of Lantus (insulin glargine) in both type 1 and type 2 diabetes mellitus patients [3].

Mylan CEO, Ms Heather Bresch said, ‘The commencement of phase III clinical trials for Mylan’s generic Advair Diskus and insulin glargine program[me]s are important milestones in the progress of two of our strategic growth drivers, demonstrating our strong capabilities in developing complex, difficult-to-manufacture products. We look forward to providing patients with access to high quality, more affordable versions of these medications upon final FDA approval.’

Mylan President, Mr Rajiv Malik added, ‘These noteworthy clinical trial developments, combined with the significant strides we have made in advancing our production scale manufacturing, reinforce our continued belief that Mylan will be the first to bring to market an AB-rated, substitutable generic form of Advair Diskus and one of the first to bring to market an interchangeable insulin analogue to Lantus.’

Related articles
Predicting the response of diabetes patients to biosimilar insulin

Sandoz gains Belgian approval for generic inhalation device

Sandoz gains Danish approval for innovative asthma inhaler

Advair could face competition from generics as early as 2016

References
1.   GaBI Online - Generics and Biosimilars Initiative. Making generics of Advair could be difficult [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Generics/News/Making-generics-of-Advair-could-be-difficult
2.   GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
3.   GaBI Online - Generics and Biosimilars Initiative. Mylan starts phase III trials for biosimilar insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/Mylan-starts-phase-III-trials-for-biosimilar-insulin-glargine

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