Study confirms Sandoz biosimilar etanercept has equivalent efficacy to originator

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks.

The innovative design of the EGALITY study includes switched and continuous treatment arms. Patients who switched treatments crossed over between biosimilar etanercept and the originator product three times with no clinically meaningful differences in safety and efficacy.

"These encouraging data demonstrate that, for patients who received three treatment switches with biosimilar etanercept and the originator product in an alternating fashion, there was no impact on the things that matter most to patients and clinicians; safety and efficacy,” said Tim de Gavre, Head of Specialty, Sandoz UK. “This innovative study marks an important milestone for Sandoz biosimilar etanercept as this will instil confidence in the safety and efficacy of this medicine.”

The 52-week EGALITY study was a randomised, double-blind trial which involved 531 adult patients with moderate to severe plaque psoriasis. The study was done over 12 months in 74 dermatology clinical sites across Europe – including the UK – and South Africa, and consisted of three treatment periods. In the first 12-week period, patients received biosimilar etanercept or the originator product. In the second period, patients with at least 50% improvement of psoriasis symptoms were re-randomised into four groups; the first two groups continued with their original treatment and other two switched to the alternate treatment every 6 weeks until week 30.1 In the third period, the patients continued to receive their last treatment at week 30 up to week 52.

From baseline to week 52, the percentage change in Psoriasis Area and Severity Index (PASI) score was comparable between biosimilar etanercept and the originator product. EGALITY also confirms a comparable safety profile of the two medicines over 52 weeks, with similar incidence rates of treatment-emergent adverse events seen in all study arms. The primary endpoint of achieving equivalence in PASI 75 response rates were met at week 12. These data were presented at the congress of the Psoriasis International Network (PIN), 2016.

The FDA approved Sandoz biosimilar etanercept in August 2016 for all indications included in the label of the originator product, which is used to treat various inflammatory conditions including rheumatoid arthritis, plaque psoriasis and psoriatic arthritis. It is currently under regulatory review by the EMA after the submission was accepted in the second half of 2015.