Hyrimoz® (adalimumab) is a biosimilar biologic drug (biosimilar) to HUMIRA®.
Indications have been granted on the basis of similarity between HYRIMOZ® and the reference biologic drug HUMIRA®.
HYRIMOZ (adalimumab injection) treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC), hidradenitis suppurativa (HS), psoriasis (Ps) or adult uveitis (NIU), and familiar with the HYRIMOZ efficacy and safety profile.
HYRIMOZ is indicated for:
• reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HYRIMOZ can be used alone or in combination with methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs).
When used as first-line treatment in recently diagnosed patients who have not been previously treated with methotrexate, HYRIMOZ should be given in combination with methotrexate. HYRIMOZ can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is contraindicated.
Polyarticular Juvenile Idiopathic Arthritis
• in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). HYRIMOZ can be used as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate (see CLINICAL TRIALS, Pediatric, Polyarticular Juvenile Idiopathic Arthritis, Study Results). Adalimumab has not been studied in pediatric patients with polyarticular juvenile idiopathic arthritis aged less than 2 years.
• reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients. HYRIMOZ can be used in combination with methotrexate (MTX) in patients who do not respond adequately to methotrexate alone.
• reducing signs and symptoms in patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Adult Crohn’s Disease
• reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants. HYRIMOZ is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
• treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies. The efficacy of adalimumab in patients who have lost response to or were intolerant to TNF blockers has not been established.
• treatment of active moderate to severe hidradenitis suppurativa in adult patients, who have not responded to conventional therapy (including systemic antibiotics).
• treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, HYRIMOZ should be used after phototherapy has been shown to be ineffective or inappropriate.
• treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.
Hyrimoz® is the fifth Sandoz biosimilar available in Canada.
Click hereto consult the product monograph of Hyrimoz®
* Hyrimoz® is a registered trademark owned or used under license by Sandoz Canada Inc.
** Humira®is a registered trademark of Abbvie Biotechnology in Canada.