Novartis’ Sandoz gains EC approval for biosimilar Hyrimoz across multiple therapeutic areas

In a significant advancement for biopharmaceuticals, Novartis’ division Sandoz has secured approval from the European Commission (EC) for Hyrimoz (adalimumab), a biosimilar to AbbVie’s Humira. This approval encompasses all indications of the reference drug, including treatment for rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis, and ulcerative colitis, marking a pivotal step in broadening access to critical therapies across Europe.

Hyrimoz’s EC approval was underpinned by extensive analytical, preclinical, and clinical research, confirming that the biosimilar matches Humira in safety, efficacy, and technical quality. The pharmacokinetics, immunogenicity, and safety profiles of Hyrimoz were validated through a rigorous randomized, double-blind, three-arm, parallel study. This study successfully met its primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters.

Further reinforcing its efficacy, the Phase 3 ADACCESS trial specifically addressed the treatment’s performance in patients with moderate to severe chronic plaque-type psoriasis, showing therapeutic equivalence with Humira. According to Novartis, this trial confirmed that there were no meaningful clinical differences in safety and immunogenicity profiles compared to Humira.

Stefan Hendriks, Global Head of Biopharmaceuticals at Sandoz, commented on the approval, stating, “We believe in making access happen for patients who are suffering from chronic inflammatory diseases. Earlier and expanded access to important, disease-modifying, biologic medicines can fundamentally change how patients manage their health. Biosimilars such as Hyrimoz can also play a transformational role in healthcare system sustainability – so we look forward to making Hyrimoz, and other important biosimilar medicines, broadly available.”

Hyrimoz works by blocking tumor necrosis factor (TNF), a protein overproduced in certain autoimmune conditions, leading to inflammation and tissue destruction. This mechanism of action is crucial for treating diseases where the immune system mistakenly attacks the body’s own tissues, such as in rheumatoid arthritis and ulcerative colitis.

The approval of Hyrimoz is part of Novartis’ broader strategy to enhance global healthcare through innovative yet cost-effective solutions. This strategy includes a recent deal where Novartis will acquire exclusive global rights to the atopic dermatitis drug MOR106 from MorphoSys and Galapagos, potentially reaching up to $1.1 billion, underscoring its commitment to expanding its dermatological portfolio.