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Multicenter, Double-Blind, Randomized, Parallel-group, Study Evaluating PK, Efficacy, Safety, and Immunogenicity in Patients With Plaque Psoriasis Receiving Humira or AVT02 Followed by a Safety Extension Phase of AVT02

Trial Profile

Multicenter, Double-Blind, Randomized, Parallel-group, Study Evaluating PK, Efficacy, Safety, and Immunogenicity in Patients With Plaque Psoriasis Receiving Humira or AVT02 Followed by a Safety Extension Phase of AVT02

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jun 2024

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Pharmacokinetics; Registrational
  • Acronyms ALVOPAD X
  • Sponsors Alvotech

Most Recent Events

  • 23 Feb 2024 According to an Alvotech media release, the company announced that based on clinical data from AVT02-GL-101, AVT02-GL-301, and AVT02-GL-302 studies, the U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.
  • 20 Sep 2023 According to an Alvotech media release, company announced that the FDA accepted Alvotech's resubmitted Biologics License Application (BLA) for AVT02. The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date February 24, 2024 for approval of the resubmitted AVT02 BLA.
  • 24 Jul 2023 According to an Alvotech media release, the company announced that Teva and Alvvotech have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech.The partners continue working closely on matters concerning pending approval in the U.S. for AVT02.

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