Spectrum to develop biosimilar monoclonal antibody

Biosimilars/News | Posted 04/03/2011 post-comment0 Post your comment

California-based Spectrum Laboratories announced on 5 January 2011 that it has signed an agreement with contract research organisation Viropro for the development of a biosimilar version of Roche’s blood-cancer drug Rituxan (rituximab).


Rituximab is a monoclonal antibody cancer (antineoplastic) medication which works by interfering with the growth of cancer cells by slowing their growth and spread in the body. It is indicated for use in the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, and rheumatoid arthritis.

Although the financial terms of the agreement were not disclosed, Viropro confirmed that the agreement calls for payments of milestones over an expected 36 months and for payment of royalties from ensuing sales.

Spectrum Pharma Chairman, President and CEO Dr Rajesh Shrotriya said that they are “excited at the opportunity to develop their own proprietary biosimilar formulation of rituximab in anticipation of patent expirations for rituximab over the coming years”.

Dr Rajiv Datar, President and CEO of Viropro commented that they were “extremely pleased to announce the signing of this agreement”.

Several generics manufacturers are already lining up for a piece of the rituximab pie. Dr Reddy’s already has a biosimilar version, Reditux, on the market in India and several other countries, while Israeli generics giant Teva Pharmaceutical Industries is conducting clinical studies comparing its biosimilar version to Roche’s drug.

The patents on Rituxan expire in 2012 in the US and in 2014 in the EU. Worldwide sales of rituximab in 2009 were US$5.6 billion (Euros 4.1 billion).

Related articles

EMA adopts guideline on biosimilar monoclonal antibodies

Hurdles to entering the biosimilars’ market

The biosimilars challenge

Source: Spectrum Pharmaceuticals, Viropro

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010