Positive phase III results for Celltrion’s rituximab biosimilar

Biosimilars/Research | Posted 09/12/2016 post-comment0 Post your comment

Phase III studies of a rituximab biosimilar from Celltrion have, according to the company, shown that the biosimilar is ‘equivalent’ to Roche’s MabThera/Rituxan (rituximab).

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South Korean biotechnology company Celltrion announced on 5 December 2016 that its pivotal phase III study ‘shows equivalence in pharmacokinetic and safety data between CT-P10 and reference rituximab’.

The phase I/III randomized, parallel-group, active-controlled, double-blind, multicentre, international study was designed to demonstrate the equivalence of pharmacokinetics (PK) and non-inferiority of efficacy of CT-P10 compared to Rituxan when each is co-administered with cyclophosphamide, vincristine and prednisone (CVP) in patients with advanced (stage III-IV) follicular lymphoma (AFL), a form of non-Hodgkin lymphoma. The study is being carried out in Barcelona, Spain and is expected to be completed in June 2020.

A total of 121 AFL patients were enrolled in a 1:1 ratio (59 patients on CT-P10 and 62 patients on reference rituximab) to demonstrate PK similarity of CT-P10 to reference rituximab, each given in combination with standard chemotherapy of CVP.

The results were presented at the 2016 American Society of Hematology (ASH) Annual Meeting. They showed, according to Celltrion, ‘equivalent PK and similar pharmacodynamics (PD), immunogenicity and safety profiles of CT-P10 to those of reference rituximab for up to 12 weeks’.

These results are in line with previous results from CT-P10 in patients with rheumatoid arthritis (RA), which were at the 2016 American College of Rheumatology (ACR) Annual Meeting and the Annual European Congress of Rheumatology (EULAR). Celltrion says that these results, along with those for AFL patients, build on the ‘evidence of similarity’ for CT-P10.

Celltrion received approval from the Korean Ministry of Food and Drug Safety (MFDS) for its rituximab biosimilar in November 2016 [1]. The company submitted its application for approval to the European Medicines Agency (EMA) in November 2015 [2]. While rival biosimilars maker Sandoz submitted the marketing application for its rituximab biosimilar to EMA for approval in May 2016 [3].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

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Biosimilars of rituximab

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-Korea 
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits rituximab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-rituximab-biosimilar-application-to-EMA 
3. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-from-Sandoz-accepted-for-review-by-EMA 

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Source: Celltrion, ClinicalTrials.com

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