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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