The launch of Hyrimoz gives Sandoz 5 biosimilars on the Canadian market. National policies on switching have given biosimilars a tailwind.
Sandoz Canada said it has launched low-concentration forms of an adalimumab injectable biosimilar (Hyrimoz), which is indicated for 9 of the 12 conditions of the originator product (Humira), including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, hidradenitis suppurativa, psoriasis, and adult uveitis.
As of late 2020, Health Canada had approved 35 biosimilars for marketing in the country, according to Sandoz. Grassroots efforts by regulators and health authorities in provinces and territories of Canada are rapidly advancing the use of biosimilars as a cost-savings measure and to free capital for the expansion of care to serve other needs.
The Ontario Drug Policy Research Network estimated that nonmedical and mandatory switching policies in all provinces for etanercept and infliximab biosimilars could have generated $239.6 million in national savings in 2019. The market for adalimumab in Canada is estimated at 42,000 patients.
Adalimumab is a tumor necrosis factor blocker that reduces inflammation. Sandoz said the product will be offered in 40-mg/0.8 mL and 20-mg/0.4mL doses in single-use prefilled syringes and in a 40-mg/0.8 mL dose in the SensoReady pen autoinjector, designed for patients with limited dexterity.
Authorization for the marketing of Hyrimoz was issued by Health Canada in December 2020. The approval marked the fourth biosimilar approval in Canada in 11 months for Sandoz, whose biosimilars portfolio in Canada now encompasses oncology, immunology, and endocrinology products.
Sandoz said the Hyrimoz launch will be supported by a patient support program to aid with reimbursement navigation, financial assistance, administrative support, and education about the use of biosimilars.
For more information about adalimumab biosimilars and market trends, click here.
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.