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.

"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."

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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."