Sandoz Enbrel Biosimilar Gets Okay from FDA

August 31, 2016

Sandoz won FDA approval for its biosimilar version of Enbrel.

Sandoz, a Novartis division that produces biosimilars, announced on August 30, 2016 that FDA approved Erelzi (etanercept-szzs), a biosimilar to etanercept, for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second biosimilar from Sandoz approved in the United States. The FDA approval follows a unanimous vote (20-0) by the FDA's Arthritis Advisory Committee (AAC) in July to recommend use in all indications of the reference product. In briefing documents submitted before the panel, FDA officials said the drug had no clinically meaningful differences from its reference product.

The approval is based on a package of analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency and is currently undergoing review. In a statement, Sandoz says it plans to launch five biosimilars of major oncology and immunology biologics by 2020. The company plans to submit 11 filings over a three-year period, and has already submitted six.

Source: Novartis