A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Latest Information Update: 07 Nov 2021
At a glance
- Drugs Adalimumab (Primary) ; Corticosteroids; Methotrexate
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Sponsors Amgen
- 04 May 2021 According to an Amgen media release, AMGEVITA was approved in Canada based on a robust data package supporting biosimilarity to the reference product, Humira, based on analytical, nonclinical, pharmacokinetic and clinical data, including results from two confirmatory clinical studies conducted in moderate-to-severe psoriasis (PsO) and moderate-to-severe rheumatoid arthritis (RA) patients.
- 15 Jun 2019 Results (n=30) evaluating marketed kits for measurement of Adalimumab, drug concentration and anti-drug antibody levels in patient serum presented at the 20th Annual Congress of the European League Against Rheumatism
- 24 Oct 2018 Results assessing injection site reactions and pain presented at the 26th United European Gastroenterology Week