Noticia de Contratación

The CHMP opinion recommends the proposed Sandoz biosimilar adalimumab for treatment of all indications of its reference medicine including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.

Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those in rheumatology, gastroenterology and dermatology.

The comprehensive data package comprises analytical, preclinical and clinical data, and demonstrates that proposed biosimilar adalimumab matches the reference biologic in terms of safety, efficacy and quality. A randomized, double-blind, three-arm parallel study was conducted to determine the pharmacokinetics, immunogenicity and safety of biosimilar adalimumab. The study met its primary objective in demonstrating PK bioequivalence.

Additionally, clinical studies submitted for review include the Phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis.