Manitoba, Saskatchewan, Alberta and Newfoundland are the most recent Canadian provinces to add Sandoz’s biosimilar Erelzi (etanercept) to their provincial medication plans for the treatment of several inflammatory diseases, including juvenile idiopathic arthritis (JIA) — juvenile arthritis of unknown cause (idiopathic).
Erelzi, like its reference product Enbrel (etanercept), is a TNF-alpha inhibitor. It acts by blocking TNF-alpha — a pro-inflammatory cytokine (small proteins secreted by cells in the immune system) involved in many inflammatory diseases. A biosimilar is a compound highly similar to its reference product, but it is not a generic drug.
Erelzi is the first biosimilar approved for JIA treatment. It was granted approval by Health Canada in April 2017 and launched later on in August; it also received approval in Europe in July 2017. In the U.S., Erelzi has been approved since August 2016 for the same indications.
The Canadian provincial listings became effective on March 1, 2018 in Alberta, April 1 in Saskatchewan and Newfoundland, and April 19 in Manitoba.
Erelzi was first added to British Columbia and Prince Edward Island’s public drug plans in November 2017. Ontario became the third province to provide public access to Erelzi in January 2018, followed by New Brunswick, Yukon and Quebec.
“Erelzi adds to the options that patients and rheumatologists have to treat inflammatory arthritis such as rheumatoid arthritis, ankylosing spondylitis and juvenile arthritis,” Walter Maksymowych, chief medical officer for CaRE Canadian Research and Education in Arthritis, said in a press release.
Erelzi is the only biosimilar that is reimbursed for the treatment of polyarticular JIA in Canadian patients aged 4 to 17. JIA is estimated to affect approximately three out of 1,000 children and teens in Canada. The drug will also be reimbursed, according to specific criteria, for the treatment of active rheumatoid arthritis in adults and active ankylosing spondylitis.
“We are pleased that Manitoba, Saskatchewan, Newfoundland, and Alberta recognize the important impact that access to Erelzi can have on reducing the burden of disease and delivering important savings to the healthcare system and the public drug plan,” said Karine Matteau, executive director of biopharmaceuticals at Sandoz.
Erelzi has been studied in a global development program that included a comparison of Erelzi and Enbrel at the analytical, preclinical, and clinical levels. The program included preclinical studies, pharmacokinetic studies, and the Phase 3 confirmatory EGALITY (NCT01891864) clinical trial, which confirmed the safety and efficacy of Erelzi when compared to Enbrel.
The EGALITY study also provided the evidence needed for the Health Canada approval in 2017.
Erelzi is available as a pre-filled syringe (25 mg and 50 mg) and in the SensoReady auto-injector pen — an ergonomic device designed for patients with limited dexterity.
Biosimilars can increase access to effective treatments, as well as reduce the economic burden of the public healthcare system. A biosimilar can only be launched after the loss of patent exclusivity on the reference biologic and, for approval, a biosimilar must demonstrate comparable efficacy, safety, tolerability and immunogenicity profiles to the reference product.