Rituximab similar biologic launched in India

Biosimilars/News | Posted 28/08/2015 post-comment0 Post your comment

India-based generics maker Hetero Group (Hetero) announced on 3 August 2015 the launch of its product Maball, a ‘similar biologic’ of rituximab, in India.

Rituxan V13C29

Maball is a similar biologic of Roche’s blockbuster drug MabThera/Rituxan (rituximab), which was approved by the US Food and Drug Administration (FDA) in November 1997 and by the European Medicines Agency (EMA) in June 1998 [1]. MabThera is indicated for the treatment of rheumatoid arthritis, non-Hodgkin lymphoma and chronic lymphocytic leukaemia.

Maball is Hetero’s second similar biologic. The company launched its first ‘similar biologic’ product Actorise, a ‘similar biologic’ of darbepoetin alfa, in India in June 2014 [1]. Dr Bandi Parthasaradhi Reddy, CMD, Hetero Group said that ‘biosimilars is one of the key strategic business areas for Hetero. We have invested in biosimilars and will introduce more biosimilar mAbs in the future’. Hetero says it is also planning to introduce its rituximab similar biologic ‘into key markets outside India’ through its partners.

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 European Union. The EMA (European Medicines Agency) 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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1. GaBI Online - Generics and Biosimilars Initiative. Darbepoetin alfa ‘similar biologic’ launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/Darbepoetin-alfa-similar-biologic-launched-in-India

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Source: Hetero

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