Psoriasis Biosimilar Comparable to Reference Product

A recent study found that Sandoz’s biosimilar, etanercept, is equally as effective as the reference product, Enbrel in treating plaque psoriasis.

Results from the EGALITY study, published by the British Journal of Dermatology, demonstrated that etanercept was equivalent to Enbrel in more than 500 patients over a 52-week time span.

Included in the year-long study were 531 patients with moderate-to-severe plaque psoriasis who either received continuous treatment with 1 of the drugs, or switched between the biosimilar and the reference product 3 times.

For the first 12 weeks, patients received the biosimilar or the reference product, and patients who had at least 50% improvement in symptoms were then randomized into new groups. The first 2 groups continued their original treatment, and the other 2 received the alternate treatment every 6 weeks until week 30, according to the study.

After 30 weeks, patients continued to receive their current treatment until week 52. At the end of the study, investigators found that the Psoriasis Area and Severity Index (PASI) score was similar between etanercept and Enbrel.

Investigators also discovered switching between etanercept and Enbrel did not show any clinical differences in safety and efficacy, according to the study.

EGALITY demonstrates the comparable safety profiles of the biosimilar and the reference product due to similar rates of adverse events in all groups, according to the findings, which were also presented at the congress of the Psoriasis International Network 2016.

Etanercept received FDA-approval for all of the indications of the originator product, which includes rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. Sandoz reported that the drug is currently undergoing regulatory review by the European Medicines Agency after the submission was accepted in 2015.

Sandoz has 3 biosimilars on the market, including etanercept, and plans to launch at least 5 oncology and immunology drugs by 2020.

"Despite the impressive medical advances of the past century, access to medicines remains the single largest unmet healthcare need in developed and developing countries alike,” Richard Francis, division head and CEO of Sandoz said in a previous press release. “Biologics have revolutionized treatment of many disabling and life-threatening diseases but far too many people who need these medicines are not able to access them. At Sandoz, we are committed to significantly broadening patient access to biologics with a series of major biosimilar launches over the next few years.”

The latest findings from the EGALITY trial show their continuous commitment to increasing patient access to treatments, as well as providing lower cost options.

“Sandoz recognizes that clinicians need robust data on switching to confidently prescribe biosimilars. In EGALITY the same patients received treatment with biosimilar etanercept and the originator product in an alternating fashion and these three treatment switches had no impact on safety and efficacy,” said Malte Peters MD, Head Global Clinical Development, Biopharmaceuticals, Sandoz. “This innovative study demonstrates that Sandoz is at the frontier of building trust and confidence in biosimilars to increase access to biologics for patients worldwide.”