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.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.