The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended the granting of a marketing authorization for two biosimilars highly similar to Humira (adalimumab, AbbVie).

Humira is an alpha inhibitor of tumor necrosis factor licensed in the European Union on September 8, 2003. The two biosimilar products are indicated for the treatment of certain inflammatory and autoimmune diseases, including: rheumatoid arthritis, psoriasis, psoriatic arthritis, and Crohn's disease. The committee proposes that both biosimilars be prescribed by clinicians experienced in the treatment of the conditions for which they are used.

Idacio

Idacio (Fresenius Kabi) will be sold in 40 mg injectable solution in a pre-filled syringe and a pre-filled pen and 40 mg / 0.8 ml for children.

The 40 mg injectable solution is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondylitis, psoriatic arthritis, psoriasis, pediatrics plaque psoriasis, hidradenitis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, uveitisand pediatric uveitis.

The 40mg / 0.8mL solution for injection is indicated for the treatment of juvenile idiopathic arthritis, pediatric plaque psoriasis, pediatric Crohn's disease, hidradenitis suppurativa in pediatric patients. teenager and uveitis in the child.

Kromeya

Kromeya (Fresenius Kabi) will also be available as a 40 mg injectable solution in a pre-filled syringe and a pre-filled pen, as well as a 40 mg / 0.8 mL solution for use in children.

The 40 mg injectable solution is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, Crohn's disease, pediatric Crohn's disease, colitis, uveitis and pediatric uveitis.

The 40 mg / 0.8 mL solution for injection is for the treatment of juvenile idiopathic arthritis, pediatric plaque psoriasis, pediatric Crohn's disease and pediatric uveitis.

The summary of product characteristics for each biosimilar will include detailed recommendations for the use of the product and will be published in the European Public Assessment Report, which will be available in all the official languages ​​of the European Union. after authorization of placing on the market by the European Commission.

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