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16-12-2019 | Rheumatology | News | Article

approvalsWatch

​​​​​​​EMA recommends adalimumab biosimilar for approval

medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended a new adalimumab biosimilar for approval in Europe.

The biosimilar – marketed under the brand name of Amsparity – has been shown to have comparable safety and efficacy profiles to its reference product.

It is recommended for the same indications as adalimumab, including rheumatoid arthritis, polyarticular and enthesitis-related juvenile idiopathic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, and psoriatic arthritis.

The biosimilar will be available as a 40 mg solution in a prefilled syringe for adults, while two formulations, 20 mg in a pre-filled syringe and 40 mg/0.8 mL in a vial, will be available for pediatric use.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group