The European Medicines Company’s Committee for Medicinal Merchandise for Human Use instructed marketing and marketing authorization this week for two recent adalimumab biosimilars, Hukyndra and Libmyris.
The biosimilars, both developed by STADA Arzneimittel AG, could be available as a 40-mg resolution for injection in a pre-filled syringe and pre-filled pen, and 80-mg resolution for injection in a pre-filled syringe. Every biosimilars might bear 15 indications:
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rheumatoid arthritis
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polyarticular juvenile idiopathic arthritis
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enthesitis-connected arthritis
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ankylosing spondylitis
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axial spondyloarthritis with out radiographic proof of ankylosing spondylitis
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psoriatic arthritis
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continual plaque psoriasis (adults and children)
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hidradenitis suppurativa
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Crohn’s disease (adults and children)
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ulcerative colitis (adults and children)
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uveitis (adults and children)
Records deliver that both Hukyndra and Libmyris are extremely equivalent to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis relate alpha, and bear comparable quality, safety, and efficacy.
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