Hyrimoz EC approval : Novartis biosimilar of AbbVie Humira approved in EU
Hyrimoz EC approval : Novartis’ Sandoz has bagged approval for Hyrimoz (adalimumab), a biosimilar of AbbVie’s Humira (adalimumab), in Europe for all indications of the reference drug including rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis and ulcerative colitis.
The approval of Hyrimoz by European Commission (EC) was driven by analytical, preclinical and clinical research that showed that the Sandoz biosimilar is on par with Humira in terms of safety, efficacy as well as technical quality.
The pharmacokinetics, immunogenicity and safety of Hyrimoz were confirmed by a randomized, double-blind, three-arm, parallel study, said Novartis.
The trial met the primary endpoint, proving bioequivalence for all primary pharmacokinetic parameters.
On the other hand, a Phase 3 confirmatory safety and efficacy study, named ADACCESS, showed therapeutic equivalence in the sensitive indication of patients having moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to Humira. No meaningful clinical differences were seen during the trial, said Novartis.
Commenting on Hyrimoz EC approval, Stefan Hendriks – Global Head of Biopharmaceuticals, Sandoz, said: “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.”
According to Novartis, Hyrimoz blocks tumor necrosis factor (TNF), a protein that is produced in excess in certain autoimmune conditions like rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis-causing inflammation and tissue destruction in joints, mucosa or skin.
In certain cases of autoimmune disease, the immune system causes damage to the body’s own tissues. Hyrimoz can be a potentially suitable treatment option for some patients across a range of indications, said Novartis. Hyrimoz functions by targeting and inhibiting the protein that leads to disease symptoms.
In another update, Novartis said it will acquire the exclusive global development and marketing rights of atopic dermatitis drug MOR106 from MorphoSys and Galapagos in a deal that could reach up to $1.1 billion.
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