Alvotech and STADA’s Uzpruvo/AVT04 is an ustekinumab biosimilar with similar efficacy, tolerability, safety and physicochemical and biological characteristics to Stelara, the reference product, as has been summarized in a recent study published in Clinical Drug Investigation [1].
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. [2].
Uzpruvo is the first ustekinumab biosimilar approved in Europe [3, 4] intended for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis, and Crohn’s disease†.
The review shows AVT04 was found to have physicochemical characteristics similar to those of reference ustekinumab, and the pharmacokinetic similarity of the molecule was demonstrated in healthy volunteers. This result came from a randomized, multicentre, double-blind, 3-arm, parallel group phase 1 study involving 298 healthy adult subjects, which met both primary and secondary endpoints.
In addition, clinical efficacy was evaluated in a randomized, multicentre, double-blind, parallel-group, active-controlled, phase 3 trial in 581 patients with moderate to severe chronic plaque psoriasis. In this trial, AVT04 demonstrated clinical efficacy similar to that of reference ustekinumab.
The same phase 3 trial also revealed that the tolerability, safety, and immunogenicity profiles of AVT04 were comparable to those of the reference ustekinumab. After the primary endpoint, patients in the reference product arm were re-randomized to either remain on the reference product or to start with AVT04. Results demonstrated that the switch had no impact on efficacy, safety, or immunogenicity.
Through a strategic collaboration since 2019, Alvotech is responsible for the development and production of AVT04/Uzpruvo, while STADA holds the commercial rights to Uzpruvo within Europe. STADA is already marketing six other approved biosimilars: Movymia (teriparatide); Hukyndra (adalimumab); Cegfila*(pegfilgrastim); Silapo (epoetin zeta); Oyavas (bevacizumab); Ximluci (ranibizumab).
Uzpruvo was launched in Europe in July 2024 and was the first ustekinumab biosimilar to reach the market.
†Uzpruvo is currently not approved for the ulcerative colitis indication, since the originator still has exclusivity for this indication
*STADA markets the Cegfila pegfilgrastim biosimilar (previously Pegfilgrastim Mundipharma) under license in certain countries, predominantly Germany.
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References
1. AVT04: An Ustekinumab Biosimilar | Clinical Drug Investigation
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 26]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 26]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-ustekinumab-biosimilar-uzpruvo
4. GaBI Online - Generics and Biosimilars Initiative. EC approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 26]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-first-ustekinumab-biosimilar-uzpruvo
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