A retrospective analysis of cancer patients who received either originator or ‘similar biologic’ rituximab chemotherapy showed comparable efficacy and safety [1].
Roche’s MabThera (rituximab), which is used in the treatment of leukaemia and non-Hodgkin’s lymphoma, a group of cancers arising from lymphocytes or white blood cells, has been used in India since 2000. India-based generics maker Dr Reddy’s Laboratories (Dr Reddy’s) received approval for its ‘similar biologic’ of rituximab (Reditux) in India in 2007 [2]. It should be noted that the official ‘Guidelines on similar biologics: regulatory requirements for marketing authorization in India’ only became effective on 15 September 2012 [3].
A study by researchers from the Tata Memorial Centre, Mumbai, India, retrospectively reviewed the charts of 223 adult diffuse large B-cell lymphoma patients who had received multi-agent chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) with rituximab between January 2004 and June 2010.
Response rates for patients who received ≥ 4 cycles of either originator or similar biologic rituximab were 88% for MabThera and 97% for Reditux. Analysis for patients who received treatment from 2007 to 2010 showed similar response rates of 83% for MabThera and 92% for Reditux.
The results showed no differences in the infusional reaction rates, grades 3 and 4 neutropenia and oral mucositis between the 101 patients that received MabThera and the 72 the received Reditux. Complete-remission rates were similar between the two groups (MabThera 75% and Reditux 82%; p = 0.294). The progression free survival rate at 5 years was 72% with MabThera and 81% with Reditux (p = 0.382). The overall survival at 5 years was also comparable between the two groups (MabThera 66% and Reditux 76%; p = 0.264).
The authors therefore concluded that ‘Reditux is as efficacious as MabThera’ in terms of response rates, progression free survival and overall survival and has comparable toxicity. ‘However, a randomized prospective trial is needed to validate these results.’
Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
Conflict of interest
The authors of the research paper [1] did not declare any conflicts of interest.
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References
1. Roy PS, et al. Comparison of the efficacy and safety of Rituximab (Mabthera™) and its biosimilar (Reditux™) in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy: a retrospective analysis. Indian J Med Paediatr Oncol. 2013;34(4):292-8.
2. GaBI Online - Generics and Biosimilars Initiative. Dr Reddy’s plans EU launch for biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 2]. Available from: www.gabionline.net/Biosimilars/News/Dr-Reddy-s-plans-EU-launch-for-biosimilar-rituximab
3. GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 2]. Available from: www.gabionline.net/Guidelines/Indian-guidelines-for-similar-biologics
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