Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Intranet
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

FDA Approves Phase III RA Clinical Trial for Celltrion’s Zymfentra™ (SC Infliximab)

Aug 19, 2024

Celltrion announced on 19 August 2024 that the FDA has approved a phase 3 clinical trial of Zymfentra™ (CT-P13 SC, infliximab SC) for rheumatoid arthritis (RA).

In October 2023, Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA, for ulcerative colitis and Crohn’s disease.  Celltrion launched Zymfentra™ in the US in March 2024.

Zymfentra™ is known as Remsima SC® in Europe.  Remsima SC® has been approved in Europe since 2013.