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.