Celltrion has South Korean approval for Truxima a rituximab biosimilar to treat all indications of the originator drug MabThera/Rituxan.
Celltrion has now South Korean Ministry of Food and Drug Safety approval for biosimilar rituximab (originator drug MabThera/Rituxan) as Truxima (formerly CT-P10) for all indications including NHL, CLL and RA. An application was approval was submitted by Celltrion in the EU in October 2016.
Data was presented by Celltrion at the ACR 2016 meeting and demonstrated that the efficacy and safety profile of rituximab biosimilar in RA patients was comparable to original rituximab over 24 weeks, according to Celltrion Healthcare, which conducts worldwide marketing, sales and distribution activities for Celltrion’s biologics. A total of 372 RA patients (161 patients on rituximab biosimilar and 211 on original rituximab) were enrolled in a Phase III trial that looked at safety and efficacy and pharmacokinetic/pharmacodynamic equivalence. Results from the study showed that the overall profiles between the two products were highly similar or equivalent across all these measures.
Comment:Competitors for rituximab include GP 2013 from Sandoz, for which EMA has accepted a filing and Mabion S.A. which aims to file Mabion CD 20 in the EU in early 2017.
Comment: Patent expiry of MabThera occurred in the EU in November 2013 and in the US for Rituxan in September 2016.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins