Mon-15-09-2025, 19:33 PM
Good to see you back sunnyman, as far as I know you are our first member going on to Uzpruvo but being a biosimilar of Stelara I would imagine it would give the same results.
It has gone through the same tests as Stelara and other biosimilars (Pyzchiva, Steqeyma, Wezenla) so basically it's the same thing but may have some small changes in the format.
Good luck and please do keep us updated, it may help others in the future.
It has gone through the same tests as Stelara and other biosimilars (Pyzchiva, Steqeyma, Wezenla) so basically it's the same thing but may have some small changes in the format.
Quote:
Evidence supporting safety and efficacy:
The clinical efficacy, safety profile and immunogenicity of ustekinumab biosimilars and Stelara, the reference product, are similar. For each product, two comparative studies were submitted to support the biosimilar licence application.
Uzpruvo (Stada, Thornton & Ross)
A randomised, double-blind, efficacy and safety study in 581 patients with moderate to severe plaque psoriasis demonstrated similarity in clinical efficacy between Uzpruvo (biosimilar ustekinumab, AVT04) and ustekinumab reference product. The mean PASI improvement for Uzpruvo vs. reference product was 87.3% vs. 86.8% (90% CI: −2.14%, 3.01%) after 12 weeks. Safety profiles remained comparable between Uzpruvo and reference product.
In a randomised, double-blind, single dose pharmacokinetic study 298 healthy adults received 45mg Uzpruvo (biosimilar ustekinumab; AVT04), EU or US reference product (Stelara). After pre-specified protein content normalisation, the study demonstrated primary outcomes of pharmacokinetic parameters within pre-specified equivalence margins. Safety and immunogenicity were comparable between products.
Good luck and please do keep us updated, it may help others in the future.