As Generic Version of Lung Disease Drug Advair Awaits Approval, Threat for GSK’s Version of the Drug Rises

Published By : 12 Jan 2016 | Published By : QYRESEARCH

As the pace of research and development in the field of medicine continues to skyrocket on a global front, the market is also seeing the entry of novel medications, many innovative medical molecules, and cheaper generic versions of many highly popular and top-selling medicines of some of the most prominent pharmaceutical companies on a constant basis.

The global pharmaceutical industry is highly competitive and features intensive capital investments aimed at the development of new and more effective drugs. Pharmaceutical giants, along with investing vast amounts of funds towards research and development activities, also spend vast funds towards the approval and marketing of their products. While these costs are covered through the high prices placed on new and effective medicines by these companies, the threat of cheaper, generic medicines eating-up most of the shares of these suddenly once-popular medicines constantly haunts major pharmaceutical companies.

GlaxoSmithKline, the British pharmaceutical company based in London, finds itself at the center of a similar situation as the company Mylan N.V. is seeking the approval of a generic and cheaper version of GlaxoSmithKline’s top-selling Advair for lung diseases.

An official statement of Mylan, released on Monday, stated that the company had filed the application for the approval of a new drug to the U.S. Food and Drug Administration (U.S. FDA) in December.

If the product gets approved under a standard period of review, a generic and cheaper version of Advair, which can be routinely substituted for GSK’s high-profile version, could be launched in 2017.

The news should not come as a big surprise to investors, since GSK itself assumes that the sales of Advair in the U.S. could fall to 300 mn pounds in 2020 from an estimated 1.97 bn in 2014 if the market sees the entry of substitutable generics.

Mylan’s announcement about its new generic medicine for Advair comes at a time when GSK is looking for market recovery in 2016.

Novartis’ Sandoz is also working on a generic version of Advair and the entry of such cheaper version is likely to put more pressure on the respiratory drugs market, also affecting the market for similar products such as Symbicort of AstraZeneca.

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