Clinical Edge

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FDA Approves Hyrimoz for Chronic Conditions

Sandoz news release; 2018 Oct 31

Sandoz has announced that the US Food and Drug Administration (FDA) approved its

biosimilar, Hyrimoz (adalimumab-adaz) for the treatment of rheumatoid

arthritis (RA), juvenile idiopathic arthritis (JIA) in patients ≥4 years, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

Sandoz, a Novartis division, is headquartered in Holzkirchen, Germany.

Dosage/administration: Hyrimoz is administered by injection: 40 mg/0.8 mL in a single-dose pre-filled glass syringe (with BD UltraSafe Passive Needle Guard) or injection: 40 mg/0.8 mL in a single-dose pre-filled pen (Sensoready Pen). For full dosage/administration information, visit: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf

Adverse reactions: The most common adverse reactions (incidence > 10 %) are infections (eg upper respiratory, sinusitis), injection site reactions, headache, and rash.

Citation:

Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz). [news release]. Holzkirchen, Germany: Sandoz. October 31, 2018. http://hugin.info/134323/R/2223385/871319.pdf. Accessed November 8, 2018.

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