Global generic and specialty pharmaceuticals company Mylan is set to start a Phase III clinical trial of its generic version of GlaxoSmithKline’s (GSK) Advair Diskus and its insulin analogue to Sanofi’s Lantus.
Currently, two Phase III clinical trials for Mylan’s insulin analogue programme are already underway.
In August, the company initiated INSTRIDE 1 and INSTRIDE 2 open-label, randomised, multicentre, parallel-group clinical trials to compare the efficacy and safety of Mylan’s insulin Glargine with that of Lantus in both type 1 and type 2 diabetes mellitus patients.
Mylan noted that the purpose of both studies is to test whether its insulin Glargine once-daily is non-inferior to Lantus once-daily when administered in combination with other anti-diabetic drugs.
Both studies are expected to be completed in June 2016.
The generic Advair Diskus trial is a randomised, double-blind, double dummy, parallel group study. It is expected to begin in October and be completed in April 2015.
It is primarily conducted to determine the local equivalence of multiple doses of Mylan’s generic product to Advair Diskus when administered through oral inhalation in adult asthma patients.
The study’s primary endpoint is the FEV1 area under the effect curve, which is the volume of air that has been forcibly exhaled in one second, after full inspiration. It will also assess adverse events and device usability.
Mylan CEO Heather Bresch said: "The commencement of Phase III clinical trials for Mylan’s generic Advair Diskus® and insulin Glargine programmes 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 Rajiv Malik said: "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 analog to Lantus."