EMA Panel Backs Adalimumab Biosimilar Amsparity

Megan Brooks

December 16, 2019

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Pfizer's Amsparity, a biosimilar copy of AbbVie's adalimumab (Humira).

Amsparity is "highly similar" to the reference product approved for use in the European Union in September 2003, the EMA said in a news release, with "comparable quality, safety and efficacy."

Amsparity will be available as a solution for injection (40 mg in a pre-filled syringe and pre-filled pen; and for pediatric use, 20 mg in a pre-filled syringe and 40 mg/0.8 mL in a vial).

Once approved, Amsparity will be indicated for use in specific adult and pediatric patients with certain inflammatory and autoimmune disorders, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis.

Detailed recommendations for the use of Amsparity will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

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