Fresenius Kabi receives European Commission approval for adalimumab biosimilar IDACIO
- IDACIO?* is Fresenius Kabi?s first biosimilar approved by the European Commission in all indications of the reference product** in the areas of rheumatology, gastroenterology and dermatology
- IDACIO? has demonstrated equivalent pharmacokinetics, efficacy, safety and immunogenicity to the reference product in the clinical development program(1,2,3).
- IDACIO? will facilitate more patient access to effective treatment options in Europe***
- Hyland E, et al. Comparison of the pharmacokinetcis, safety and immunogenicity of MSB11022, a biosimilars of adalimumab, with Humira? in healthy subjects. Br J Clin Pharmacol. 2016;82(4):983?932
- Hercogova J et al. A randomized, double-blind trial comparing the efficacy, safety and immunogenicity of MSB11022, a proposed biosimilar of adalimumab, versus adalimumab originator in patients with moderate-to-severe plaque psoriasis. Am Acad Dermatol. 2018;79(3):AB21
- Hercogova J et al. Safety, immunogenicity, and efficacy after a single switch from reference adalimumab to the proposed biosimilar MSB11022: Longterm results from a randomized, double-blind, 52-week, phase III study in moderate-to-severe plaque-type psoriasis patients Am Acad Dermatol.