A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade and US Sourced Remicade) in Healthy Subjects
Phase of Trial: Phase I
Latest Information Update: 12 Jul 2017
At a glance
- Drugs Infliximab (Primary)
- Indications Rheumatoid arthritis
- Focus Pharmacokinetics; Registrational
- Sponsors Samsung Bioepis
- 30 May 2016 According to a Biogen media release, The European Commission (EC) has granted marketing authorization in the European Union (EU) for FLIXABI (Infliximab Biosimilar) based on the data from this and a phase III trial (see profile 235251).
- 23 May 2016 According to Merck media release, Biologics License Application (BLA) of SB2 (infliximab) by Samsung Bioepis has been accepted for review by the U.S. Food and Drug Administration (FDA).
- 01 Apr 2016 According to a Samsung Bioepis media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi, a biosimilar version of Remicade (infliximab).