Sandoz won't pursue US biosimilar rituximab
Citing a US Food and Drug Administration call for additional information, Swiss pharma giant Novartis’ (NOVN VX) biosimilars division Sandoz has decided that it will not pursue its submission for biosimilar rituximab, used to treat certain cancer and rheumatoid arthritis in the USA at this time. .
Sandoz, which in May received a complete response letter from the agency, says it will focus on progressing its biosimilar pipeline in areas of greatest unmet access needs, noting that its rituximab biosimilar is already approved in the European Union, Japan and Australia.
The originator product is Swiss rival Roche’s (ROG: SIX) Rituxan/MabThera, which posted sales for the first nine months of this year of 5.11 billion Swiss francs ($5.122 billion).
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