Advair Generics Likely Lucrative Product For Few That Can Clear High Bar
With release of draft bioequivalence guidance for GSK’s blockbuster asthma and COPD treatment, generics seem more likely than ever, but there may be only a select number of companies who can meet the guidance’s requirements.
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US FDA approves Teva’s fluticasone/salmeterol fixed-dose combination product under the 505(b)(2) NDA route with an asthma indication but no labeling claim for chronic obstructive pulmonary disease.
Amgen, Celgene, Mylan and Gilead were among the companies that provided business updates at the Cowen and Co. Healthcare conference and Raymond James Institutional Investors conference.
CEO Andrew Witty reconfirmed that GSK’s respiratory business will return to growth in 2016 and said the company’s five-year outlook does not depend on the timing of a generic Advair. Mylan recently filed what is believed to be the first ANDA for a generic Advair Diskus in the US.