Regulatory Affairs

Novartis’ etanercept biosimilar approved in Europe to treat inflammatory diseases

PBR Staff Writer Published 28 June 2017

The European Commission (EC) has approved Novartis’ Erelzi, the biosimilar of Amgen and Pfizer’s Enbrel (etanercept), for the treatment of multiple inflammatory diseases.

Developed by Novartis’ unit Sandoz, Erelzi has been approved as an alternative option for all indications of the reference drug.

Erelzi can be used by physicians to treat rheumatoid arthritis, axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis, juvenile idiopathic arthritis and pediatric plaque psoriasis.

The EC approval follows a pharmacokinetic (PK) study that proved Erelzi’s bioequivalence in the pharmacokinetic profiles. It was also demonstrated to be on par with Enbrel when it comes to safety, tolerability and immunogenicity.

Prior to that, Sandoz carried out a late-stage phase 3 study called EGALITY which produced confirmatory efficacy, safety and immunogenicity data for Erelzi in comparison to its reference medicine.

Sandoz biopharmaceuticals global head Carol Lynch said: "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.

"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."

Sandoz has launched the drug in a pre-filled syringe and an auto-injector pen dubbed as SensoReady.

The EC approval for Erelzi takes Sandoz’ tally of approved biosimilars in Europe to five.