India-based generics company Intas Pharmaceuticals (Intas) announced the launch of a ‘similar biologic’ – as the Indian regulatory authorities call these products –version of rituximab in India.
Rituximab is a chimeric mouse-human monoclonal antibody that binds to the CD20 antigen presented on the B cell surface. It is used for treatment of diseases characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells. Such diseases include many forms of lymphoma, leukaemia, and transplant rejection, as well as autoimmune disorders such as rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's Granulomatosis) and microscopic polyangiitis.
Intas’ ‘similar biologic’ is called Mabtas and it is hoped that it will provide cost-effective treatment for patients with non-Hodgkin’s Lymphoma. It may be used alone or in combination with other chemotherapy medicines to treat non-Hodgkin's Lymphoma and chronic lymphocytic leukaemia.
Indian companies are leading the way when it comes to monoclonal antibodies. EMA is yet to approve any monoclonal antibody biosimilars in Europe, although it is currently reviewing two applications for approval of infliximab biosimilars for the treatment of arthritis [1]. Several companies have also recently stopped trials for rituximab biosimilars. In October 2012, Teva Pharmaceutical Industries stopped their phase III trial and Samsung halted its clinical development for rituximab biosimilars [2, 3], while Celltrion stopped its planned phase III trial in the first quarter of 2013 [4].
‘Similar biologics’ have been on the market in India for some years and India has by far shown the greatest acceptance of such products. However, regulatory guidelines for ‘similar biologics’ were only implemented in September 2012. Prior to this ‘similar biologics’ were approved in India following the generics pathway, but with more data being required [5].
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 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.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA –2013 Q1 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q1
2. GaBI Online - Generics and Biosimilars Initiative. Teva halts phase III biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 10]. Available from: www.gabionline.net/Biosimilars/News/Teva-halts-phase-III-biosimilar-rituximab-trial
3. GaBI Online - Generics and Biosimilars Initiative. Samsung halts biosimilar rituximab development www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 10]. Available from: www.gabionline.net/Biosimilars/News/Samsung-halts-biosimilar-rituximab-development
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion stops phase III trial of biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 10]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-stops-phase-III-trial-of-biosimilar-rituximab
5. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 10]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
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