Novartis gains EU approval for biosimilar version of Roche's MabThera

Novartis' Sandoz unit said Monday that the European Commission approved Rixathon as a biosimilar version of Roche's MabThera (rituximab). Sandoz noted that the product has been authorised for use in all indications that MabThera is cleared for, including non-Hodgkin's lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis.

According to Sandoz, the approval of Rixathon was based on a number of studies demonstrating that the drug matches MabThera in terms of safety, efficacy and quality. Results from the ASSIST-RA trial showed that Rixathon and MabThera have equivalent pharmacokinetic/pharmacodynamic profiles, with no clinically meaningful differences in safety, tolerability or immunogenicity in patients with rheumatoid arthritis. Meanwhile, the ASSIST-FL study met its main goal of equivalence in overall response rate between Rixathon and Roche's product after six months.

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Carol Lynch, global head of biopharmaceuticals at Sandoz, noted that "Rixathon will be one of the five major launches we plan in the next four years." The company has four biosimilar medicines approved in Europe.

MabThera, which is also marketed as Rituxan, generated sales of 7.3 billion Swiss francs ($7.5 billion) last year. In February, Celltrion's Truxima became the first biosimilar version of MabThera authorised in Europe. For related analysis, see FirstWord Lists: Roche's near-term biosimilar threat in Europe.

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