Mylan preps for rejection of Advair copy
- Mylan disclosed in a short communication on Wednesday that the Food and Drug Administration will issue a Complete Response Letter for the drugmaker's generic version of GlaxoSmithKline's Advair Diskus on June 27.
- The generic drugmaker said the agency "identified minor deficiencies" that will be communicated in the CRL. Once the official rejection is received, Mylan will determine what impact it will have on its financial outlook for the year.
- Mylan was quick to point out the abbreviated New Drug Application for the generic asthma drug had a priority review and could be approved ahead of the 90-day period typical after a response to a CRL, suggesting the generic could still be approved this year.
GlaxoSmithKline just got its latest reprieve from competition to its blockbuster asthma drug-device combo Advair Diskus (fluticasone propionate/salmeterol). The drug is hard to copy because of the delivery device and GSK has been lucky that most of the companies trying to replicate it have been delayed by regulatory authorities. Both Novartis' Sandoz unit and Hikma have hit setbacks.
The entrance of an Advair copy will have huge consequences for the British drugmaker. GSK forecasted 2018 earnings per share to grow between 4% and 7% if no generic version hit the market. Yet, if a copycat launches, earnings would come in between flat or down 3%. The entrance of an Advair copy this year could put more than 50% of revenue from the drug at jeopardy.
For Mylan, this is just the latest setback. The company received a rejection for its generic Advair in March of last year.
Mylan has touted its efforts in complex generics to investors, calling the space the future for the company. The generic drugmaker says that complex generics like Advair and biosimilars make up 70% of its pipeline value.
Mylan already has approved versions of Teva Pharmaceutical's blockbuster multiple sclerosis drug Copaxone (glatiramer acetate), and is investing heavily in biosimilars, including a version of AbbVie's rheumatoid arthritis Humira (adalimumab).
Mylan's focus on complex generics comes after a pricing scandal and increased competition have pushed down sales of the EpiPen, which for years was the company's crown jewel. While EpiPen allowed the company to move away from its traditional base in generics, Mylan is now trying to get back to its roots with a focus on copycat products.
In early 2017, Teva won approval of the AirDuo RespiClick, which contains the same ingredients as Advair but is not interchangeable. The drug only has an indication for asthma patients 12 and older, while Advair is also used for patients with chronic obstructive pulmonary disease.
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