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FDA Approves Hyrimoz for Plaque Psoriasis

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 plaque psoriasis. Psoriasis is the most prevalent autoimmune disease in the US, and according to recent studies, as many as 7.5 million Americans—approximately 2.2% of the population—have psoriasis.

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

Indications: Hyrimoz is a tumor necrosis factor (TNF)-blocker indicated for treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Dosage/administration: Administered by subcutaneous injection, the recommended dosage of Hyrimoz for plaque psoriasis is 80 mg initial dose, followed by 40 mg every other week starting 1 week after initial dose.

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 2, 2018.