Novartis’ Cosentyx takes on Humira and biosimilar in phase III showdown

Novartis has launched two trials pitting its new Cosentyx product against AbbVie’s Humira and one of its biosimilars in a bid to capture market share from the world’s biggest-selling drug.

The two trials - SURPASS and EXCEED - will compare interleukin-17 antagonist Cosentyx (secukinumab) against TNF blocker adalimumab in ankylosing spondylitis and psoriatic arthritis, respectively. In the case of EXCEED the comparator will be Humira itself, while in SURPASS Cosentyx will go up against a biosimilar version of adalimumab developed by Novartis’ subsidiary Sandoz.

The intention seems to be to demonstrate clear superiority of Cosentyx against Humira itself as well as lower-priced biosimilars of the $14bn blockbuster, which are already on the market, and show that Cosentyx’s clinical efficacy trumps the cost savings of the cheaper options.

Sandoz's biosimilar matched Humira in a psoriasis trial reported last September and has been filed for approval in the EU, but is playing catch-up in the market with already-approved biosimilars, including Samsung Bioepis’ Imraldi and Boehringer Ingelheim’s Cyltezo in Europe, and Amgen’s Amgevita as well as Cyltezo in the US.

Novartis’ chief medical officer Vas Narasimhan said in a statement that the trials will “provide valuable answers for doctors and patients in their decision making” on the management of AS and PsA.

Even with current treatments like TNF inhibitors “many patients living with PsA and AS cannot enjoy a normal life as they are experiencing persistent pain and fatigue, and are at risk of long-term mobility loss,” he added.

Cosentyx was the first IL-17 inhibitor to reach the market and has been growing quickly, despite facing competition from more recent IL-17 inhibitor entrants from Eli Lilly and Valeant, as well as Johnson & Johnson’s IL-23 blocker Tremfya (guselkumab) which was approved in Europe towards the end of last year.

Initially registered for psoriasis in 2015, subsequent approvals for AS and PsA have helped Cosentyx sales grow quickly to reach $566m in the third quarter of 2017 and reach blockbuster status in its second full year on the market.

“The EXCEED and SURPASS head-to-head trials are addressing important clinical questions solving residual uncertainty for patients with PsA and AS," commented Dr Robert Landewé, professor of Rheumatology in the Amsterdam Rheumatology and Clinical Immunology Centre and the Zuyderland Medical Centre in the Netherlands.

"Head-to-head trials deliver the most robust data helping to advance clinical practice and are key to clinical decision making. In this case, these data would add to the body of evidence to underline the benefit of different biologic pathways for physicians."