Clinical Trials

Date: 2016-11-18

Type of information: Publication of results in a medical journal

phase: 3

Announcement: publication of results in The British Medical Journal

Company: Sandoz (Switzerland)

Product: biosimilar etanercept

Action mechanism:

biosimilar/TNF alpha inhibitor.Etanercept is a tumor necrosis factor alpha (TNFa) inhibitor produced using recombinant DNA technology.

The FDA approved Sandoz biosimilar etenercept 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.

Disease: moderate to severe chronic plaque-type psoriasis

Therapeutic area: Autoimmune diseases – Dermatological diseases

Country: Bulgaria, Czech Republic, Estonia, Germany, Hungary, Poland, Romania, Russian Federation, Slovakia, South Africa, Ukraine, UK

Trial details:

The 52-week EGALITY study was a randomized, double-blind trial which involved 531 adult patients with moderate to severe plaque psoriasis. The study was carried out over 12 months in 74 dermatology clinical sites across Europe 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-randomized into four groups; the first two groups continued with their original treatment and other two switched to the alternate treatment every six weeks until week 30. In the third period, the patients continued to receive their last treatment at week 30 up to week 52. (NCT01891864)

Latest news:

 * On November 18, 2016, Sandoz announced the publication of the EGALITY study in the British Journal of Dermatology. The confirmatory clinical safety and efficacy study shows Sandoz biosimilar etanercept is equivalent to the originator product, Enbrel®, in more than 500 adult patients over 52 weeks. The 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.
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.
* On June 24, 2013,  Sandoz has announced it has initiated a major Phase III clinical trial with its biosimilar version of etanercept (Amgen's Enbrel®). The global clinical trial will seek to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel® in patients with moderate to severe chronic plaque-type psoriasis.  The global clinical program was developed in consultation with regulatory authorities in the U.S. and EU, and the results from this clinical trial are expected to support regulatory submissions in both the U.S. and EU.

Is general: Yes