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FDA approves Sandoz’s Enbrel biosimilar for multiple inflammatory diseases

The US Food and Drug Administration (FDA) has approved Sandoz’s Erelzi, a biosimilar to Amgen's Enbrel, to treat several inflammatory diseases.

Erelzi is approved for all indications present in the reference product's label including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).

The approval follows unanimous support from the regulator's Arthritis Advisory Committee on the back of evidence that Erelzi is highly similar to the US-licensed reference product.

The FDA stated that Erelzi has been approved as a biosimilar, not as an interchangeable product.

FDA Center for Drug Evaluation and Research director Janet Woodcock said: “The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

Erelzi is also currently being reviewed in Europe, where the first biosimilar version of Enbrel, made by Samsung Bioepis, was approved earlier this year.

Sandoz is planning to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020.