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15-10-2021 | Rheumatology | News | Article

approvalsWatch

EMA recommends approval of two adalimumab biosimilars

Author: Claire Barnard

medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended approval of two adalimumab biosimilars for the treatment of various rheumatic diseases.

The agents, marketed under the brand names of Libmyris and Hukyndra, are indicated for the treatment of rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis, as well as other immune-mediated diseases including uveitis and inflammatory bowel disease.

The EMA’s recommendation is based on data showing that the two biosimilars have comparable quality, safety, and efficacy profiles to the adalimumab reference product.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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