Sandoz’s biosimilar etanercept, Erelzi, referencing the brand-name Enbrel, has been granted an indication for the treatment of psoriatic arthritis by Health Canada.
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.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.