Mylan’s generic of best-selling GSK drug delayed by FDA

pharmafile | March 30, 2017 | News story | Sales and Marketing Advair, GSK, Mylan 

Mylan’s plan to bring its generic competitor to GSK’s best-selling respiratory drug, Advair, has hit a major snag after it received a complete response letter (CRL) from the FDA. The news will arrive as a boost for in-coming GSK CEO Emma Walmsley, as the delay of generic competition should see Advair’s annual sales protected in the short-term.

GSK had prepared its financial guidance to investors under the presumption that a generic competitor would arrive in 2017. Advair managed sales of $1.83 billion last year in the US and expected this figure to fall to $1.24 billion in 2017 if a generic did receive FDA approval.

Much depends on the details of the CRL that Mylan received from the FDA. If the issues the agency took on the generic were only minor then Mylan can refile in two months and could potentially still have its generic approved mid-way through 2017. It is a situation Mylan will be hoping for, as it has, according to Mylan CEO, Heather Bresch, already pumped $800 million into getting its own drug to market.

Mylan released a statement on the CRL which read: “In conjunction with Mylan’s GDUFA goal date, the company received a complete response letter from FDA regarding its ANDA for generic Advair Diskus. Mylan is in the process of reviewing this response and will provide an update on its application as soon as practicable once it has completed its review and discussed the FDA’s feedback with the agency.”

The setback will come as a blow to Mylan, which had worked closely with the FDA on its application. However, many within the industry are not unduly surprised by the announcement – with many citing the fact that the approval would be the first time a complex inhaled combination generic would be approved by the FDA.

Beyond Mylan, GSK still faces the threat of another generic competitor that has been put forward by Hitma Pharmaceuticals, with a decision expect on its generic due by 10 May.

Ben Hargreaves

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