Pharma Focus Europe

Sandoz Enters US Immunology Market With Launch of Hyrimoz® (Adalimumab-adaz) High-concentration Formulation

Monday, July 03, 2023

Sandoz, a global leader in generic pharmaceuticals and biosimilars, has announced the launch of the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz) injection in the United States starting July 1.

Hyrimoz HCF (100 mg/mL) has received approval to treat all indications that are no longer covered by the regulatory exclusivity for the reference medicine, Humira®* (adalimumab), as of July 1, 2023. These indications include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

According to Keren Haruvi, President North America, Sandoz Inc., this launch is a significant moment for both Sandoz and the millions of patients in the US living with chronic inflammatory diseases. Sandoz aims to expand access to important medicines for patients, and the introduction of Hyrimoz in the US immunology market aligns with that commitment. Haruvi emphasized that Hyrimoz offers another treatment option for patients who need adalimumab but may have previously faced challenges accessing or affording this critical medicine.

The Hyrimoz HCF formulation provides a 50% reduction in injection volume compared to the 50 mg/mL concentration, potentially reducing the number of injections required for patients needing at least 80 mg/0.8 mL dosing. It is also citrate-free and uses the same Sensoready® pen auto-injector as Hyrimoz 50 mg/mL. The Sensoready pen is designed to be user-friendly, featuring an ergonomic design, buttonless injection for self-administration, and a 360° viewing window for visual feedback.

Sandoz has established Sandoz One Source for Hyrimoz, a comprehensive patient support program that offers educational resources, reimbursement support, and affordability assistance. Patients can visit Hyrimoz.com to learn more about Sandoz One Source and Hyrimoz.

Hyrimoz® (adalimumab-adaz) contains adalimumab, an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions. By targeting and blocking this protein, Hyrimoz helps reduce inflammation and tissue destruction in conditions such as rheumatoid arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.

The specific indications for HYRIMOZ® (adalimumab-adaz) include:

  1. Rheumatoid Arthritis (RA): Treatment of signs and symptoms, induction of major clinical response, inhibition of structural damage progression, and improvement of physical function in adults with moderately to severely active RA. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

  2. Juvenile Idiopathic Arthritis (JIA): Treatment of signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate.

  3. Psoriatic Arthritis (PsA): Treatment of signs and symptoms, inhibition of structural damage progression, and improvement of physical function in adults with active PsA. HYRIMOZ can be used alone or in combination with non-biologic DMARDs.

  4. Ankylosing Spondylitis (AS): Treatment of signs and symptoms in adults with active AS.

  5. Crohn's Disease (CD): Treatment of moderately to severely active CD in adults and pediatric patients 6 years of age and older.

  6. Ulcerative Colitis (UC): Treatment of moderately to severely active UC in adult patients. Note: Effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers.

  7. Plaque Psoriasis (Ps): Treatment of moderate to severe chronic Ps in adult patients who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HYRIMOZ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

  8. Hidradenitis Suppurativa (HS): Treatment of moderate to severe HS in adult patients.                                                                      

 

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