Tony Hagen is senior managing editor for The Center for Biosimilars®.
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.