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.
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.