Sandoz's Etanercept Biosimilar, Erelzi, Added to Ontario Public Drug Plan

In August 2017, Sandoz, a Novartis company, announced the launch of its etanercept biosimilar (Erelzi) in Canada. In December 2017, Ontario became the most recent Canadian province to add the biosimilar etanercept to its public drug plan for the treatment of multiple inflammatory diseases.

Etanercept is the only biosimilar to be reimbursed for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17. Etanercept is also reimbursed under specific criteria for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults, and for reducing symptoms of active ankylosing spondylitis (AS).

Janet Pope, MD, professor of medicine in the division of rheumatology, epidemiology, and biostatistics at the university of Western Ontario, Schulich School of Medicine, London, said in a statement, “The biosimilar Erelzi adds to the choices that patients and rheumatologists have to treat inflammatory arthritis such as [RA], [AS,] and juvenile arthritis. The government of Ontario is demonstrating its commitment to making therapy for these diseases more broadly available in order to improve the lives of more patients.”

Although the biosimilar was also approved by the FDA in August 2016, the drug has yet to be launched in the US market. The launch of this drug could be delayed until later this year, at the earliest, due to ongoing patent-infringement litigation with reference drug maker, Amgen. In an interview with Reuters, Richard Francis, division head of Sandoz for Novartis, said “That’s the frustration sometimes of the legal situation, but the way I look at that, we’re carving the landscape out as we go.”

In an effort to seek a competitive edge for their reference product, in November 2017, Amgen launched an ergonomically designed cartridge with a reusable auto-injector in the United States as an additional administration option to its reference etanercept (Enbrel). The Auto Touch reusable auto-injector is used with Enbrel Mini single-dose prefilled cartridges (50 mg/Ml) that utilize a new drug formulation of etanercept that was associated with substantially lower mean injection site pain than the previous formulation, according to an Amgen study.

While reference product sponsors seek to improve the delivery of biologics and maintain control of market share, the marketing of Erelzi in the European Union and Canada has been in both an auto-injector and pre-filled syringe delivery devices.