Hikma in dispute with FDA over Advair generic

While Sandoz has emerged as the front-runner to get a generic version of GlaxoSmithKline’s respiratory blockbuster Advair to the US market, rival Hikma has not given up despite a major setback.

The FDA rejected Advair generics from Mylan and Hikma earlier this year and in May, Sandoz filed its generic contender, making it the most likely to capture a share of the lucrative asthma and COPD market that GSK has dominated for so long.

Advair’s US patent expired years ago but GSK has managed to maintain blockbuster-level sales becauuse no-one has a generic rival past the FDA.

The regulator has been tough with copies of drug-device combination products and Hikma and partner Vectura are on the back foot as a result.

Advair (salmeterol+fluticasone), known as a Seretide in Europe, generated sales of £743 million in the third quarter, with sales of £388 million in the US, meaning it is still GSK’s biggest selling product.

But Hikma said it has now resolved many of the issues that caused the rejection, following “constructive discussions” with the FDA.

The Jordan-based London-listed firm said in a trading update that there is still an “outstanding issue” with a clinical endpoint study.

The outcome of the dispute will be known in the first quarter of 2018, when Hikma will update the market and provide details of regulatory timelines.

Mylan also said in May that it was in dispute with the FDA over its decision to reject its rival Advair copy, although it has not produced any further updates since then.

In the trading update, Hikma said it expected global injectables revenue to be around $775 million with a margin of around 39%, although competition could intensify in 2018.

Shares in the company fell 6% on the London Stock Exchange to 983p following the announcement.