Both Idacio and Kromeya will, if granted marketing authorizations by the European Commission, be available as 40-mg solutions for injection. Kromeya will carry indications for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, Crohn disease in adults and children, ulcerative colitis, uveitis in adults and children. Idacio will the same indications, but also indications in hidradenitis suppurativa in adults and adolescents.
The European Commission currently permits duplicate marketing authorizations for products, including biosimilars, on a case-by-case basis.
Fresenius Kabi’s submission of MSB11022 included analytical, pharmacokinetic, efficacy, safety, and immunogenicity data. The phase 3 study for the molecule, AURIEL-Psoriasis, met its primary endpoint of demonstrating clinical equivalence to the reference adalimumab. The safety and immunogenicity of MSB11022 were also comparable to reference adalimumab in the clinical studies, and data to support switching were included.
“Obtaining this positive CHMP opinion is a significant achievement for Fresenius Kabi and reinforces our commitment to deliver our biosimilars portfolio to patients,” said Michael Schönhofen, PhD, member of the Fresenius Kabi management board and president of the pharmaceuticals division, in a statement announcing the CHMP opinion. “If marketing authorization is granted by the European Commission, Fresenius Kabi will provide patients in the European Union with an additional treatment option in all indications of the reference product,” he added.
The EC’s decision on the biosimilar brands is expected in the second quarter of 2019. If approved, the adalimumab biosimilar brands will be authorized for marketing in the EU member states, and European Economic Area states will take corresponding marketing decisions.
Per the terms of an October 2018 settlement with Humira-maker AbbVie, Fresenius Kabi will be permitted to launch its adalimumab in the EU marketplace immediately following EC authorization, and Fresenius Kabi will pay AbbVie royalties on the sales of its product. While the biosimilar developer has not yet received FDA clearance for its adalimumab, it has also agreed with AbbVie that it can market the drug in the United States beginning on September 30, 2023.