A comparative pharmacokinetic study of Etanercept (GP2015) in healthy volunteers
Phase of Trial: Phase I
Latest Information Update: 30 Aug 2016
At a glance
- Drugs Etanercept (Primary)
- Indications Ankylosing spondylitis; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis
- Focus Pharmacokinetics
- 30 Aug 2016 According to a Sandoz media release, the US FDA has approved biosimilar etanercept (Erelzi) for all indication included in the reference product label. Data from this and four other trials supported the approval.
- 26 Jul 2016 New trial record
- 13 Jul 2016 According to a Sandoz media release, the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. Data from this trial supported the recommendation.