Novartis division Sandoz has secured marketing authorization from the European Commission (EC) for its biosimilar Hyrimoz (adalimumab) for use in all same indications as reference medicine including rheumatology, gastroenterology and dermatology.
It is the fourth Sandoz biosimilar approved in Europe in past 18 months, and seventh in total.
Hyrimoz is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in various autoimmune conditions, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis-causing inflammation and tissue destruction in joints, mucosa or skin.
The immune system damages the body’s own tissues in some cases of autoimmune disease. Hyrimoz is said to act by targeting and blocking the protein that leads to disease symptoms.
Sandoz has received approval based on a comprehensive data package, which included analytical, preclinical and clinical research that demonstrated Hyrimoz matches the reference biologic in terms of safety, efficacy and technical quality.
A randomized, double-blind, three-arm and parallel study proved the pharmacokinetics, immunogenicity and safety of Hyrimoz.
The study achieved the primary endpoint, showing bioequivalence for all primary pharmacokinetic parameters.
The firm’s phase III confirmatory safety and efficacy study (ADACCESS) showed therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis with a similar safety and immunogenicity profile to the reference biologic.
Sandoz said Hyrimoz is its seventh approved biosimilar medicine in Europe and additional biosimilars for oncology and immunology indications are expected to be launched across major regions in the world by 2020.
Sandoz biopharmaceuticals global head Stefan Hendriks 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.”
Sandoz, which is based in Holzkirchenin of Germany’s Greater Munich area, is engaged in the development of generic pharmaceuticals and biosimilars.
The company’s portfolio of about 1,000 molecules, covers all major therapeutic areas, accounted for 2017 sales of $10.1bn.