Dr Reddy’s plans EU launch for biosimilar rituximab

Biosimilares/Novedades | Posted 14/09/2012 post-comment0 Post your comment

India-based generics drugmaker Dr Reddy’s Laboratories (Dr Reddy’s) is planning to launch its biosimilar monoclonal antibody Reditux (rituximab) in Europe.


The drug is a biosimilar version of 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.

The company is in talks with European regulators about the potential launch of Reditux, according to DNA India. The product is the world’s first biosimilar monoclonal antibody and is expected to be commercialized in partnership with Merck Serono, a division of Merck KGaA.

Reditux was introduced in India in April 2007 at 50% of the original price in India, producing a 10-fold market expansion for the product. In 2010–11, domestic revenues from Reditux grew 75% making the product the fourth-largest brand in Dr Reddy’s portfolio. The company has also had impressive growth of 45% during 2011 and sales of US$26 million for its biosimilars business as a whole.

While declining to outline a timetable for the European launch, a spokesperson for Dr Reddy’s told DNA India that ‘Europe is an attractive market for it and we are actively pursuing it.’

This comes as part of a wider corporate strategy to further explore the commercial potential of biosimilars, having signed partnerships with GlaxoSmithKline and Merck Serono in this area.

The partnership between Dr Reddy’s and German pharmaceutical firm Merck KGaA, was agreed in June 2012 and covers co-development, manufacturing and commercialization of a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies [1]. Dr Reddy’s will handle early product development until the end of Phase I, after which Merck Serono will take over responsibility for later-stage trials and manufacturing operations.

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1.  GaBI Online - Generics and Biosimilars Initiative. Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Sep 14]. Available from: www.gabionline.net/Biosimilars/News/Merck-KGaA-and-Dr-Reddy-s-to-collaborate-on-biosimilar-mAbs

Source: DNA India, Dr Reddy’s, Roche, The Times of India

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