Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF

Next Previous
Trial Profile

A Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Mar 2023

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis; Uveitis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Sandoz

Most Recent Events

  • 21 Mar 2023 According to Sandoz media release,US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection to treat seven indications covered by the reference medicine, Humira (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohns disease, ulcerative colitis and plaque psoriasis.
  • 21 Mar 2023 According to Sandoz media release, the company intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023.
  • 30 Jan 2023 According to Sandoz media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation of adalimumab. The authorization includes all indications covered by the reference medicine: rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and uvetis.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top