Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Hyrimoz® - biosimilar version of Humira® (adalimumab)
Compound: adalimumab - biosimilar version of Humira®
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases - Digesti
- biosimilar/monoclonal antibody/TNF alpha inhibitor. Adalimumab is a monoclonal antibody that binds specifically to TNF alpha and blocks its interaction with cell surface TNF receptors. It is used to treat many conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis.
Company: Sandoz (Switzerland)
- plaque psoriasis, rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa, non-infectious uveitis
- • On July 27, 2018, Sandoz announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz® (adalimumab) for use in all indications of the reference medicine Humira®, including rheumatoid arthritis, plaque psoriasis, Crohn's disease, uveitis and ulcerative colitis. The approval was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz® matches the reference biologic in terms of safety, efficacy and technical quality. A randomized, double-blind, three-arm, parallel study confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A Phase III confirmatory safety and efficacy study (ADACCESS) demonstrated 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. No meaningful clinical differences were observed.
- • On May 31, 2017, Sandoz, a Novartis division, announced that the European Medicines Agency (EMA) has accepted for regulatory review its Marketing Authorization Applications for biosimilar to AbbVie’s Humira® (adalimumab) Sandoz is seeking approval for biosimilar adalimumab for use in all indications of their respective reference medicines. The biosimilar adalimumab submission included clinical data from pharmacokinetic (PK) studies and a Phase III confirmatory efficacy and safety study in patients with moderate to severe chronic plaque psoriasis.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE: 2018-07-27
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: