Usgena (ustekinumab; STADA  Arzneimittel AG) — a biosimilar for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis — has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), which recommended its approval at its September meeting as an accessible alternative to existing biologics.

The active substance of Usgena, ustekinumab, is an immunosuppressant interleukin (IL) inhibitor. It functions as a fully human IgG1κ monoclonal antibody that selectively targets the p40 subunit common to IL-12 and IL-23. By inhibiting the interaction of these cytokines with the IL-12 receptor subunit beta 1 on immune cell surfaces, ustekinumab disrupts downstream signaling involved in the differentiation and activation of Th1 and Th17 cells. This mechanism modulates key inflammatory pathways implicated in the pathogenesis of immune-mediated conditions such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

The CHMP mentioned that Usgena shows comparable quality, safety, and effectiveness to the reference medicine Stelara (ustekinumab), which gained European Union approval on January 15, 2009. 

The EMA evaluates biosimilars using the same rigorous standards as for all biological medicines. Developers must demonstrate high similarity to the reference product, with no clinically meaningful differences, through comprehensive comparability studies.

The biosimilar will be available in various formulations, including 45 mg and 90 mg injection solutions in vials or prefilled syringes, plus a 130 mg concentrate for infusion solution in vials.

Usgena is intended to treat:

• Moderate-to-severe plaque psoriasis in adults and in children aged 6 years or older who are inadequately controlled by, or intolerant to, other systemic therapies or phototherapy
• Psoriatic arthritis, either alone or with methotrexate to address active disease in adults when previous nonbiological, disease-modifying antirheumatic drug therapy proves insufficient
• Adults with moderately to severely active Crohn’s disease who experience poor or lost response to conventional therapy or TNF alpha antagonists or who cannot tolerate them
• Adults with moderately to severely active ulcerative colitis who have poor or lost response to conventional therapy or biologics or who cannot tolerate them

Usgena requires use under the direction and oversight of physicians skilled in diagnosing and managing the conditions for which the medicine is approved. 

Detailed recommendations for Usgena use will be described in the summary of product characteristics, which will be published on the EMA website after the European Commission grants marketing authorization.