According to GlobeNewswire, Health Canada has approved of a biosimilar, Hyrimoz, to treat ankylosing spondylitis and eight other rare conditions. Sandoz Canada is excited about this approval, as it expands their biosimilar profile even further. They have had three biosimilars approved in the past eleven months.
Hyrimoz is a fully humanized tumor necrosis factor (TNF) blocker, meaning that it is able to treat inflammation. It is administered in a subcutaneous form, and has been approved for the following dosages: 40 mg/0.8 mL in autoinjector, 20 mg/0.4mL in prefilled syringe, and 40 mg/0.8 mL in a prefilled syringe.
This treatment is also a biosimilar, meaning that it has proven extreme similarity with no differences in the safety and efficacy profiles to an approved, original-brand biologic. When patents for the original biologic expire and data protection periods end, other biosimilars are allowed to become commercially available.
Approval for Hyrimoz
Health Canada officially approved of Hyrimoz on November 4, 2o20. This approval covers nine rare diseases, including ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, and uveitis.
This approval can lead to increased access to treatment, as 42,000 Canadians are currently taking the original-brand biologic treatment. More treatment options means expanded access. A patient support program will also be created, which will help patients with reimbursement, administrative support, financial assistance, and even education.
Sandoz aims to launch Hyrimoz by February 15, 2021.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a disorder that causes inflammation in the spine that may spread to other body parts. Symptoms include inflammation of the hips, eyes, knees, shoulders, and joints of the spine and ribs. This inflammation can make breathing and other movements difficult, and issues with the eyes can lead to vision loss. In a small number of cases, the nervous system, lungs, and heart are affected. In terms of a cause, medical professionals believe that a number of environmental and genetic reasons are behind AS. The exact cause is unknown, but there have been multiple genes linked to the disorder. Biologics and NSAIDs are used to treat AS, but a special diet and exercise routine have both been proven to reduce the symptoms.