- The Food and Drug Administration has approved the first generic copy to GlaxoSmithKline's combination lung therapy Advair Diskus, clearing Mylan's Wixela Inhub on Wednesday for use in asthma and chronic obstructive pulmonary disease (COPD).
- Past rejections have delayed arrival of Mylan's copycat twice before, at times frustrating investors in the generic drugmaker. Now approved, Wixela Inhub will bring pressure on GlaxoSmithKline, which has been planning for generic competition to Advair for years.
- News of the approval sent shares in Mylan higher by 7% on Wednesday. Mylan will market the generic inhaler at three different dose levels, all of which will be available in the second half of February, the company said Thursday.
Mylan tested investors' patience over the past four months, teasing in October that approval of its generic version of Advair Diskus (fluticasone/salmeterol) was imminent.
That patience has finally paid off with an approval for the generic, which, like Advair, combines two drugs at a fixed dose delivered through an inhalation device.
"Today's approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a Wednesday statement.
GSK's respiratory business is one of its largest, and a core focus for the company. While generic competition to Advair will dent the unit's growth, GSK hopes to offset that by driving uptake of newer brands like Nucala (mepolizumab).
For Mylan, it looks able to enjoy its status as first-to-market with a generic for some time. Copies from Novartis and Hikma aren't expected to reach market until early 2020.
"As it appears that generic Advair opportunity is for Mylan’s alone to seize for at least next 12 months, its upside potential could be significant as the product should provide a long-tailed high-margin revenue stream to Mylan," wrote Elliot Wilbur, an analyst at Raymond James, in a note to investors.
"At current levels, Mylan’s generic Advair opportunity could be $225-250M to overall sales," he stated.
That would help Mylan, which has had a tough time as of late in its North American business. Falling product volumes and prices in the generic market have led Mylan to convene a strategic review committee to assess a "wide range" of options. A manufacturing plan in Morgantown, meanwhile, has been under regulatory scrutiny.
Advair's approval is also noteworthy for the FDA, which has promoted development of generic drug/device combinations. The agency has issued dozens of guidance documents to help advance the development of generic transdermal and topical delivery systems, a push highlighted by a Wednesday statement from FDA head Scott Gottlieb.
The agency is planning additional policy steps in 2019 to promote generic competition for complex drugs, including further guidance and recommendations to industry.
In addition, the agency aims to support the development of new analytical tools and in vitro tests to support approval of complex generic drugs. These should reduce complex generic drug development time and cost and help to inform regulatory decisions.