Enbrel Biosimilar Gains Approval in Europe

Today, Sandoz announced that the European Commission has approved Erelzi (etanercept) for the treatment of all conditions indicated for the reference product, Enbrel.

In Europe, Erelzi has received approval to treat: rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis, as well as juvenile idiopathic arthritis and pediatric plaque psoriasis, according to a press release.

Erelzi is available in a pre-filled syringe and SensoReady, an auto-injector. Sandoz reports that the auto-injector has been designed for safety, comfort, and convenience.

The European approval was based on findings from a drug development program, including preclinical and clinical trials. The results from the studies demonstrated that Erelzi has the same safety, efficacy, and quality as the reference product, according to the release.

The investigators found that the pharmacokinetic profiles of Erelzi and the reference product were bioequivalent. Additionally, there were no observed differences in safety, tolerability, and immunogenicity.

Sandoz reported that the findings from the phase 3 EGALITY study confirmed the safety, efficacy, and immunogenicity of the biosimilar. The clinical trial included treatment switches between Erelzi and the reference product to determine if patients could switch drugs and retain disease control.

At 52 weeks, the investigators found that there were no differences in mean Psoriasis Area and Severity Index (PASI) responses in patients who switched between treatments and among patients continuing treatment with the biosimilar and the reference product, according to release.

The study met its primary endpoint of achieving equivalence in PASI 75 response rates at 12 weeks. The study further confirmed the comparable safety profile of the drugs over 52 weeks and the investigators found that the immunogenicity was low.

Previously, in August 2016, the FDA approved Sandoz’s Erelzi (etanercept-szzs) for all indications of the branded drug. The FDA approval resulted from positive findings from comparative pharmacokinetic studies in healthy patients and a similarity study conducted in patients with chronic plaque psoriasis.

The European approval of the biosimilar provides additional treatment options for patients with multiple inflammatory conditions, according to the release.

“Immunology is a priority for us and today’s approval of Erelzi, the second in this therapy area in as many weeks, clearly demonstrates our commitment to patients. This can also be seen in the progress we are making in our immunology pipeline with two recent file acceptances in Europe” said Carol Lynch, global head, Biopharmaceuticals, Sandoz. “As part of the wider Novartis immunology portfolio, Erelzi further expands the offering to healthcare professionals and patients in Europe. Its availability is expected to result in more patients being treated with much-needed biologics.”