Tiny Mabion Races Big Pharma To EU Rituximab Market
Poland’s biotech Mabion is racing to the European biosimilar market with a biosimilar rituximab, but is up against multinational biosimilar companies like Sandoz and South Korea’s Celltrion, and will likely need a strong commercialization partner outside its home market.
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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.
April saw the 10th anniversary of the first biosimilar approval in Europe –Sandoz International GMBH's Omnitrope (somatropin) – which was launched in 2006. But a decade on, even with 20 biosimilar products now available and many more to come as big biological drugs lose their patent protection, there are still significant barriers to biosimilar penetration and wide variations in patient access across the EU that need to be addressed.
MAbxience, a biosimilar R&D company founded in 2009 as the biotechnology arm of CHEMO group, has opened a new manufacturing plant in Leon, Spain at which it hopes to produce up to six new monoclonal antibody biosimilars for its target markets of Europe and Latin America.