News
EU CHMP recommends approval of Amgevita (adalimumab biosimilar) for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveiti-Amge
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Amgevita (adalimumab biosimilar), from Amgen, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis.
Amgevita will be available as a solution for injection (20 mg and 40 mg). Amgevita is a biosimilar medicinal product that is highly similar to the reference product Humira (adalimumab), which was authorised in the EU on 8 September 2003. Studies have shown that Amgevita has comparable quality, safety and efficacy to Humira.
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