First generic to Advair is approved after long wait

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Pom669)
(Image: Getty/Pom669)

Related tags: Gsk, Mylan, Advair

GSK’s luck at maintaining sales on its off-patent Advair product has run out, with Mylan’s generic version receiving approval from the US FDA.

Mylan’s generic will be made available in three dosage strengths for the twice-daily treatment of asthma in patients aged four years and older, as well for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

GSK had an unexpected extension to the period with which it maintained unchallenged sales to its Advair Diskus (fluticasone propionate and salmeterol inhalation powder) product, after Mylan received a complete response letter​.

This decision by the US Food and Drug Administration (FDA) saw GSK’s earnings per share boosted​, with the potential to reap additional sales.

The FDA’s Anna Abram, deputy commissioner for policy, planning, legislation, and analysis acknowledged that aiding the development of ‘complex generics’, such as in this example, is a focus for the agency.

Abram noted, "We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we're prioritising review of many applications covering proposed generic complex products for which a generic has not yet been approved."

Producing a generic version of Advair that met the FDA’s expectation had proved difficult for a number of companies. Sandoz, Hikma Pharmaceuticals and Vectura have all experienced difficulties when bringing their alternatives to Advair in front of the regulator.

A spokesperson was not available for comment regarding when Mylan’s product would reach the market.

Shares of Mylan rose 7% immediately after the news.

Related news

Show more

Related products

show more

Single-Pass Tangential Flow Filtration

Single-Pass Tangential Flow Filtration

BioContinuum™ Platform - MilliporeSigma | 01-Aug-2020 | Application Note

Tangential flow filtration (TFF) is widely used in the biopharmaceutical industry for downstream processing applications. Typical TFF steps concentrate...

Flow Cytometry Services

Flow Cytometry Services

Q2 Solutions | 01-Jun-2020 | Data Sheet

We are an established leader in flow cytometry services for clinical trials. Our technologies and solutions meet the growing global demand for enhanced...

Local lab Data Management

Local lab Data Management

Q2 Solutions | 01-May-2020 | Data Sheet

When a clinical trial requires local or point-of-care laboratory testing, managing the resulting data can be a significant burden to both the sponsor and...

Follow us

Products

View more

Webinars