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Sandoz Extrapolates Biosimilar Rituximab Data For EU Filing

 
• By John Davis

Sandoz has used data extrapolation to all the indications for Roche's MabThera in its marketing submission for biosimilar rituximab, just accepted for review by the European Medicines Agency.

R Francis
Sandoz CEO Richard Francis • Source: Sandoz.

Sandoz appears to have taken the lead in the close race to develop a biosimilar version of Roche's blockbuster TNF-inhibitor MabThera (rituximab) for Europe, announcing May 24 that the European Medicines Agency had accepted its regulatory submission for its biosimilar rituximab (GP2013).

The Novartis AG division has conducted pivotal confirmatory safety, pharmacokinetic/pharmacodynamic and efficacy studies of its biosimilar version of rituximab (GP2013) in 629 follicular lymphoma and 173 rheumatoid arthritis patients,...

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