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.

FDA’s newly released draft bioequivalence guidance outlining recommendations for generic manufacturers looking to market copies of GlaxoSmithKline PLC’s bestselling Advair Diskus (fluticasone/salmeterol) sets high hurdles that will likely only be able to be met by a limited number of ANDA hopefuls, Mylan NV President Rajiv Malik said.

While few generic players may not be comforting to GSK, which stands to lose a substantial chunk of its sales – Advair is the number two biggest drug in the world and accounts for about 18% of the company’s total sales – the

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