Sandoz Launches Biosimilar Etanercept, Erelzi, in Canada

Sandoz announced today that it has launched its etanercept biosimilar (Erelzi) in Canada. The launch follows an August 2 recommendation by Canada’s Common Drug Expert Committee (CDEC) that the Canadian health system reimburse for the biosimilar. Health Canada gave the drug a Notice of Compliance in April 2017.

In a press release announcing today’s launch, Sandoz highlighted the biosimilar’s potential to increase access to expensive biologics. The drug maker citied an Arthritis Alliance of Canada report that found that 50,000 Canadians who have rheumatic diseases have either significant difficulty in performing or no ability to perform life tasks such as dressing or walking, yet only 15% of such patients currently have access to a biologic treatment.

Michel Robidoux, president and general manager of Sandoz Canada, said, “Unfortunately, as it stands today, not all Canadians living with debilitating disease have the same access to biologics. There is a growing population that has a relatively high prevalence of immunological diseases, such as rheumatoid arthritis [RA]. Launching Erelzi is another concrete example of how Sandoz is making access happen by offering high-quality medicines at a more affordable price, which will deliver important savings to the healthcare system.”

The etanercept biosimilar is approved to treat moderate to severe RA with or without the use of methotrexate, active ankylosing spondylitis (AS), and severe polyarticular juvenile idiopathic arthritis (PJIA). It is the first biosimilar approved in Canada to treat PJIA in patients 4 to 17 years of age who have not responded adequately to 1 or more disease-modifying anti-rheumatic drugs. Sandoz states that PJIA affects 1 in 1000 Canadian children.

Canadian approval of the drug was based on the EGALITY study, a confirmatory, randomized, double-blind study that compared the efficacy, safety, and immunogenicity of Sandoz’s etanercept biosimilar to the originator product in patients with moderate to severe plaque psoriasis (PP). The study demonstrated equivalent efficacy and comparable safety and immunogenicity of the biosimilar and its reference (Enbrel). Sandoz did not seek a marketing authorization for its biosimilar for the treatment of psoriatic arthritis (PA) or PP, however.

Erelzi was also approved in the European Union in June, where it is approved for all of the indications of the originator product (RA, AS, PP, PA, PJIA, and pediatric PP).

While the biosimilar was FDA approved in August 30 2016, US patients can expect further delays in the drug’s availability. Sandoz has agreed not to launch the drug until an as-yet undisclosed date in response to a complaint, filed by Amgen, Roche, and Immunex, alleging that the Sandoz product infringes on their patents protecting the branded reference, Enbrel. Richard Francis, division head of Sandoz for Novartis, has said that he does not expect the drug to launch in the United States until 2018.