Mylan has finally muscled its generic of GlaxoSmithKline’s respiratory blockbuster Advair onto the US market, after a catalogue of delays.
The FDA approved Mylan’s version of the asthma and chronic obstructive pulmonary disease (COPD) brand yesterday, putting around $1bn in Advair sales at risk of steep decline.
In a statement, the director of the FDA’s Center for Drug Evaluation and Research (CDER) – Janet Woodcock (pictured below) – said the approval “is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives”.
Mylan’s version of the drug is called Wixela Inhub and it has made it to the market ahead of rivals from the likes of Novartis’ Sandoz unit and Hikma/Vectura, with all three generics delayed by difficulties of showing sufficient equivalence with the Diskus dry powder inhaler used in the product to meet the substitution requirements of the FDA.
Teva won approval for its AirDuo product last year in the US, providing the same active ingredients as Advair but with a lower dose of salmeterol which means it is not a direct generic, but a lower-priced branded alternative to GSK’s drug. At the same time, Teva also launched an authorised generic of its own brand to try to eat further into Advair’s market share.
Evercore ISI analysts are predicting that Mylan’s generic could make around $250m in sales this year, with the commercial opportunity much truncated because GSK has been heavily discounting its brand to retain market share.
Advair was due to face generic competition in the US last year, but the delays handed it a welcome reprieve and hundreds of millions of dollars in windfall revenues as it implemented a major restructuring drive under CEO Emma Walmsley aimed at reinvigorating the company.
It has also given GSK a bit more time to advance its three-drug COPD product Trelegy (fluticasone furoate/umeclidinium/vilanterol) as well as other new respiratory drugs – although some analysts reckon it may be interested in quitting respiratory altogether and focus its R&D investment in oncology and immunology drugs.
The approval came as the FDA announced new draft guidance that FDA Commissioner Scott Gottlieb said is part of a package of measures that will help accelerate the development of generics, including those for harder-to-copy complex drugs that “often face greater scientific and regulatory challenges and thus often have less competition.”