Sandoz’s Enbrel biosimilar meets primary endpoint in psoriasis trial

The Egality trial focused on patients with moderate-to-severe chronic plaque-type psoriasis.

The European Medicines Agency and the US Food and Drug Administration accepted for regulatory review of Sandoz biosimilar etanercept candidate in the second half of 2015.

The company is seeking approval for all indications included in the label of the originator product, which is used to treat several inflammatory conditions such as rheumatoid arthritis and psoriasis.

The randomized, double-blind Egality study was undertaken in 74 dermatology clinics in 531 patients across 11 European countries and South Africa.

Data has been collected from the patients in one year with multiple treatment switches where a patient received either the biosimilar etanercept candidate or the originator product on several alternate occasions.

Key secondary efficacy endpoints at week 12 were based on percent change from baseline in PASI, clinical safety and immunogenicity.

Sandoz head global clinical development for biopharmaceuticals Malte Peters said: "The Egality data, showing our biosimilar etanercept to be bioequivalent to the originator product, is part of the comprehensive data package submitted to the EMA and FDA.

"If our biosimilar etanercept is approved for the same indications as the originator product, more patients with chronic inflammatory conditions like rheumatoid arthritis and psoriasis will have access to life-changing biologic treatment options."

Sandoz offers a portfolio of about 1, 100 molecules, which ranges from standard generics to complex products.

Image: Sandoz is the generic pharmaceuticals division of Novartis. Photo: courtesy of –Andrew- from Flickr.