Spectrum plans to develop biosimilar Rituxan WORLD NEWS | JANUARY 06, 2011
US drugmaker Spectrum Pharmaceuticals has said it plans to develop a biosimilar version of Roche and Biogen Idec's cancer and arthritis drug Mabthera/Rituxan (rituximab), with the help of Canadian partner Viropro.
While specific financial aspects of the agreement have not been revealed, Viropro said it is a "multimillion" dollar contract and that it stands to receive milestone payments over a period of three years, as well as royalties on eventual sales. Related Links EMA publishes biosimilar friendly guidelines “Consistent global approach” to biosimilars urged Teva and Lonza JV will target potentially lucrative biosimilar market
Rituxan is Roche's second biggest-selling product with sales of almost $6 billion a year in indications including non-Hodgkin's lymphoma, chronic lymphocytic lymphoma and rheumatoid arthritis. In the past Roche has claimed patent protection for the drug until at least 2015 and possibly 2018 in the USA and 2013 elsewhere, and Spectrum has indicated only that it plans to enter the market on "patent expirations for rituximab over the coming years."
The US cancer specialist has no heritage in biosimilars. Its two commercialised products were bought-in from other companies, and it has a pipeline of novel oncology drugs both developed in-house and in-licensed. It can however offer specialist sales and marketing network in oncology, while Viropro brings its expertise in cell culture and bioprocessing technologies to the alliance.
Indeed, Viropro has made no secret of its desire to find commercial partners for its biosimilar cell lines and manufacturing processes, and its president and chief executive Dr. Rajiv Datar said the Spectrum alliance was "an important breakthrough for us in the North American market."
The announcement comes a few months after Israeli generics giant Teva Pharmaceutical Industries said it had started clinical testing of its own biosimilar version of rituximab.
Teva is expected to put in a strong bid in the emerging biosimilar market given its two-year-old alliance with contract manufacturer Lonza. That said, Spectrum would likely have to capture only a small percentage of Rituxan's market share in order to recoup a healthy return on its investment.
With over $30 billion-worth of biologic drugs losing patent protection within the coming years, analysts have estimated that biosimilars could quickly become a $10 billion category.
A number of biosimilar products are already in the market in Europe, notes Spectrum, and since the enactment of the Biologics Price Competition and Innovation Act of 2009 an abbreviated approval pathway for biosimilars has been created in the USA.
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