Trial Profile
A Comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Jun 2020
Price :
$35
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At a glance
- Drugs Etanercept (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Sponsors YL Biologics
- 04 Jun 2020 According to a Lupin media release, Lupin and Mylan has received the European Commission (EC) grant for marketing authorization for Nepexto, a biosimilar to Enbrel (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis, following the CHMP opinion.
- 04 Jun 2020 According to a Lupin media release, based on the data of this phase 3 study demonstrating the efficacy, safety and immunogenicity of Nepexto to Enbrel and preclinical and clinical studies demonstrating bioequivalence to Enbrel, a positive opinion was granted by Manjira Sharmathe Committee for Medicinal Products for Human Use (CHMP) in March 2020.
- 15 Jun 2019 Results presented at the 20th Annual Congress of the European League Against Rheumatism