Chasing Mylan, Hikma tries again with rejected generic Advair in US

UK-listed Hikma Pharma has filed a response to the FDA that it hopes will clear the way for approval of its generic of GlaxoSmithKline’s blockbuster respiratory drug Advair.

Hikma has been struggling to get approval from the FDA for its generic of the asthma and chronic obstructive pulmonary disease (COPD) treatment since 2017, when its version of Advair Diskus (salmeterol/fluticasone propionate) was first rejected byno  the agency.

It started a new trial of its generic that included clinical endpoints last year in a bid to answer FDA reservations about the product, and says the data has now been submitted to the regulator.

Advair lost patent protection in the US way back in 2010, while exclusivity on the Diskus inhaler went in 2016. However, a high threshold set by the FDA for showing equivalence for drug-device combinations delayed generic competition for years – despite rapid take-up of copycat products elsewhere in the world.

In the interim since Hikma received its complete response letter (CRL) from the FDA, it has fallen behind rivals vying to bring generic Advair to the US market. In February, Mylan launched the first generic at a 70% discount to GSK’s brand – Wixela Inhub – which was also rejected by the FDA at the first attempt in 2017.

Since the launch, Advair’s US sales have plummeted 53% to £398 million ($512 million) in the first nine months of the year, and are expected to come under further pressure if an already-filed generic from Novartis’ Sandoz unit also gets a green light.

Sandoz has said it expects to launch its drug next year, so Hikma could reach the market with two generics already eating into Advair’s market share.

Advair – known as Seretide in Europe and some other markets – remains a blockbuster for GSK with worldwide sales of £1.3 million since the start of the year, but is well down from its peak of more than $5 billion in 2013.

Hikma’s chief executive Siggi Olafsson said that the company has worked hard with Vectura – which supplies the device for the generic – to “complete a large and challenging clinical study which we believe demonstrates the safety and effectiveness of our product.”

“As we continue to develop our pipeline of complex generics, respiratory products are a key strategic focus for Hikma and our generic Advair submission is an important milestone, he added.

In the first half of this year, Hikma’s revenues – spilt across generics, injectables and branded products – grew 7% to $1.04 billion.