European Agency Recommends Two New Adalimumab Biosimilars

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris.

The biosimilars, both developed by STADA Arzneimittel AG, will be available as a 40-mg solution for injection in a pre-filled syringe and pre-filled pen, and 80-mg solution for injection in a pre-filled syringe. Both biosimilars will have 15 indications:

  • rheumatoid arthritis

  • polyarticular juvenile idiopathic arthritis

  • enthesitis-related arthritis

  • ankylosing spondylitis

  • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

  • psoriatic arthritis

  • chronic plaque psoriasis (adults and children)

  • hidradenitis suppurativa

  • Crohn’s disease (adults and children)

  • ulcerative colitis (adults and children)

  • uveitis (adults and children)

Data show that both Hukyndra and Libmyris are highly similar to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis factor alpha, and have comparable quality, safety, and efficacy.

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