Eye on Pharma: Sandoz's Biosimilar Etanercept Gains New Canadian Indication

Sandoz’s biosimilar etanercept, Erelzi, referencing the brand-name Enbrel, has been granted an indication for the treatment of psoriatic arthritis (PsA) by Health Canada.

The biosimilar was initially approved by Health Canada in 2017 to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, and ankylosing spondylitis (AS). The new indication means that the biosimilar will become a treatment option for the approximately 90,000 Canadians who have PsA, a disease that 10% to 30% of patients with psoriasis will eventually develop.

“We have the ability to improve access to different treatment options for patients suffering from this debilitating disease,” said Michel Robidoux, president and general manager of Sandoz Canada, in a statement. “The approval of Erelzi to also manage [PsA] can, in addition, help reduce healthcare system costs by making available a cost-effective biosimilar treatment option for this form of arthritis.”

In Canada, Erelzi competes with both the reference product and 1 other biosimilar, Samsung Bioepis’ Brenzys. However, Samsung’s product is approved to treat RA and AS only.

While Erelzi is also approved in the United States, having received the FDA’s authorization in August 2016, the product has not yet launched in the US marketplace. The biosimilar has been the subject of a long-running patent dispute between Sandoz and Amgen (which acquired Immunex, the original maker of the reference product). In September 2018, a 10-day trial in the case concluded, and in October 2018, the 2 drug makers each submitted post-trial briefs. The companies are now awaiting a decision from the court on the dispute, and the ruling could potentially clear the way for the biosimilar to finally make its way to US patients.

Meanwhile, stakeholders are growing frustrated with the high cost of the reference product to the US healthcare system. Last week, the House Committee on Oversight and Reform announced that it is launching a wide-ranging investigation into prescription drug pricing in the United States, and Enbrel is among the targets of that investigation for its repeated increases in price.