Ustekinumab 45mg/0.5ml solution for injection vials

Ustekinumab is a human immunoglobulin (Ig) G1 kappa monoclonal antibody directed against interleukin(IL)-12 and IL-23, which are cytokines that are involved in immune and inflammatory responses.[A187349] It was generated via recombinant human IL-12 immunization of human Ig (hu-Ig) transgenic mice.[A187349] It is a targeted biologic disease-modifying anti-rheumatic drug (bDMARDs) that is used in the management of various inflammatory conditions that involve the activation of IL-12 and IL-23 signalling pathways.[A187346]

The therapeutic use of the drug started in Canada, the US, and Europe since 2009 when it was first approved for the treatment of adult patients with moderate to severe plaque psoriasis and active psoriatic arthritis, alone or in combination with [methotrexate]. In September 2016, ustekinumab was additionally approved for the management of moderate to severe Crohn's disease in selected adult patients. In October 2019, it was also approved by the FDA for use to manage moderately to severely active ulcerative colitis in adults. Ustekinumab is currently the first and only approved biologic therapy for ulcerative colitis that targets the interleukin (IL)-12 and IL-23 cytokines.[L9392] The dosing regimen for ustekinumab is based on the patient's weight and there are intravenous and subcutaneous formulations of the drug based on the dosing schedule and condition being treated. Ustekinumab is commonly marketed under the trade name STELARA.

Ustekinumab biosimilars are available in some markets, including Wezlana[L49071], Yesintek[L52815], Selarsdi[L52820], Otulfi[L52825] and Pyzchiva[L52810] in the US, Jamteki (AVT04)[L49076], Steqeyma[L52830] and Wezlana [L52073] in Canada., Uzpruvo in the EU [L52078]