EU Panel Recommends Humira Biosimilars Idacio, Kromeya

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

Humira is a tumor necrosis factor-alpha inhibitor that was authorized in the European Union on September 8, 2003. Both biosimilar products are indicated for certain inflammatory and autoimmune disorders, including rheumatoid arthritis, psoriasis, psoriatic arthritis, and Crohn’s disease. The committee proposes that both biosimilars be prescribed by clinicians with experience treating the conditions for which they are used.

Idacio

Idacio (Fresenius Kabi) will be sold as an injectable solution with 40 mg in a prefilled syringe and a prefilled pen with 40 mg/0.8 mL solution for use in children.

The 40-mg injectable solution is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, uveitis, and pediatric uveitis.

The 40 mg/0.8 mL injectable solution is indicated for the treatment of juvenile idiopathic arthritis, pediatric plaque psoriasis, pediatric Crohn’s disease, adolescent hidradenitis suppurativa, and pediatric uveitis.

Kromeya

Kromeya (Fresenius Kabi) will also be available as an injectable solution with 40 mg in a prefilled syringe and a prefilled pen, and 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 spondylarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, uveitis, and pediatric uveitis.

The 40 mg/0.8 mL injectable solution is intended 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 use of the product and be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

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