British Columbia and Prince Edward Island have become the first Canadian provinces to add Erelzi (etanercept), a biosimilar of Amgen‘s Enbrel, to the public drug plans for the treatment of inflammatory diseases including adult and juvenile arthritis.
Biosimilars can increase patients’ access to effective treatments while reducing costs to the healthcare system.
Erelzi is the Sandoz biosimilar of the reference medicine Enbrel. Erelzi has been studied in a global development program, which compared the drug with Enbrel at the analytical, preclinical and clinical levels. The program included the Phase 3 EGALITY study (NCT01891864), which evaluated the safety and efficacy of Erelzi.
The complete body of evidence collected during these studies demonstrated that Erelzi is highly similar to Enbrel in terms of structure, function, pharmacokinetics, safety, and immunogenicity.
“The biosimilar Erelzi is a further addition to the many choices patients and rheumatologists have to fight chronic inflammatory arthritis such as rheumatoid arthritis,” John Wade, a rheumatologist at Artus Health Centre in Vancouver, Canada, said in a press release.
“As we successfully improve lives with patients who have crippling diseases, British Columbia has demonstrated the commitment to provide coverage for these important medications,” Wade added. “Biosimilars provide cost savings so that more patients can be treated at a lower cost to the healthcare system.”
Erelzi is now the first biosimilar indicated for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in these two Canadian provinces. According to Sandoz, JIA is estimated to affect about three out of 1,000 children and adolescents in Canada.
Based on results of the comprehensive clinical program comparing Erelzi and Enbrel, Health Canada approved Erelzi in April 2017 and the biosimilar was launched in Canada in August.
The approval included the indications for the reduction of signs and symptoms of moderately to severely active polyarticular JIA in patients ages 4 to 17.
Erelzi is available in two doses, 25 mg or 50 mg, in a pre-filled syringe and in the SensoReady pre-filled pen (an ergonomic device for patients with limited dexterity).
In the U.S., Amgen took Novartis (the parent company of Sandoz) to federal court earlier this year, claiming it has patent protection over Enbrel until 2029. Novartis said it will be at least 2018, if not longer, until the patent issue is resolved. The U.S. Food and Drug Administration approved Erelzi as a biosimilar in 2016.
The provincial decisions to include Erelzi in the public health system of British Columbia was made on Nov. 14 and Prince Edward Island on Nov. 27, following the conclusion of an agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) and Sandoz Canada, allowing public and federal drug plans to pay for the therapy.
“Sandoz is pleased that British Columbia and Prince Edward Island 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 Nadia Turchetta, executive director of biopharmaceuticals at Sandoz Canada.