Alvotech Initiates AVT04-GL-301 Study of AVT04 Proposed Biosimilar to Stelara (ustekinumab) for the Treatment of Plaque Psoriasis

July 7, 2021 Auto Bot Alvotech, Biosimilar, Biosimilars, Plaque Psoriasis, ustekinumab 0

Shots:

  • The first patient has been dosed in the comparative, confirmatory efficacy, and safety AVT04-GL-301 clinical study to evaluate AVT04 vs Stelara in ~ 530 patients with plaque psoriasis across five countries in the EU
  • The purpose of the study is to demonstrate therapeutic equivalence b/w AVT04 and Stelara in terms of safety, efficacy, and immunogenicity
  • Additionally, the company is also conducting an AVT04-GL-101, PK similarity study to assess equivalent PK endpoints, safety and tolerability for AVT04 in ~ 294 healthy adult volunteers across Australia and New Zealand

Click here to read full press release/ article | Ref: Businesswire | Image: Alvotech

The post Alvotech Initiates AVT04-GL-301 Study of AVT04 Proposed Biosimilar to Stelara (ustekinumab) for the Treatment of Plaque Psoriasis first appeared on PharmaShots.