Biosimilar Erelzi Approved in Canada for Juvenile Arthritis, Other Inflammatory Diseases

Biosimilar Erelzi Approved in Canada for Juvenile Arthritis, Other Inflammatory Diseases

Health Canada recently approved Erelzi, a biosimilar of Enbrel (etanercept), to treat juvenile idiopathic arthritis (JIA) and other chronic inflammatory diseases. Erelzi was developed by Sandoz, a subsidiary of the Swiss multinational company Novartis.

Erelzi is the first biosimilar approved to treat JIA. It is indicated for patients ages 4 to 17 who don’t respond to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Erelzi was approved in Europe in July 2017 and in the U.S. in August 2016 to treat multiple chronic inflammatory diseases.

Now, with the approval in Canada, doctors have the option to safely switch patients from Amgen’s Enbrel (etanercept), the original biological drug, to the new biosimilar drug.

“The EGALITY study has shown that Erelzi is safe and effective, and switching patients from Enbrel to Erelzi can be performed safely without any loss of efficacy,” Janet Pope, professor of medicine in the Division of Rheumatology, Epidemiology, and Biostatistics at the University of Western Ontario, Schulich School of Medicine, said in a press release.

For the approval, Health Canada looked at comparative studies between Erelzi and Enbrel. The two therapies were compared both at the preclinical level and in Phase 1 to Phase 3 clinical trials. The Phase 3 EGALITY trial (NCT01891864) showed a comparable safety and efficacy profile between the two drugs.

A biosimilar is a more affordable version of a biological brand-name drug already on the market. It is produced using the same techniques and processes, and it should have the same safety profile and efficacy as the original drug (demonstrated through clinical trials). Biosimilars are usually developed by a company after the patent for the original drug has expired.

“Biologics have revolutionized the treatment and prevention of many disabling and life-threatening diseases. However, they are contributing to the rising costs of healthcare, and this may restrict access to these important medicines,” said Michel Robidoux, president and general manager of Sandoz Canada.

As a result, biosimilar drugs of original biologic therapies can decrease healthcare costs and the total economic burden of the disease.

Erelzi, like Enbrel, is a TNF-alpha inhibitor. It acts by blocking TNF-alpha, a pro-inflammatory cytokine involved in many inflammatory diseases. The therapy is available in a pre-filled syringe and a pre-filled pen, SensoReady — a form easier to use.

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