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.
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.
Must Reads in FDA Actions
FDA Approves Hyrimoz for Plaque Psoriasis, Sandoz news release; 2018 Oct 31
FDA Approves Seysara for Severe Acne Vulgaris, Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2
FDA Approves Nuzyra for Acute Skin Infections, Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2
Psoriasis Treatment Receives Tentative FDA Approval, Bausch Heath news release; 2018 Oct 8
FDA Approves Libtayo for Metastatic cSCC, Sanofi news release; 2018 Sep 28