Novartis’ MabThera biosimilar wins EU nod

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Novartis is poised to turn up the pressure on sales of Roche’s monoclonal antibody MabThera/Rituxan after EU regulators approved its cheaper biosimilar version of the mega blockbuster for use across blood malignancies and immunological diseases.

The European Commission (EC) has now issued a full green light to Sandoz, Novartis’ generics arm, to market Rixathon (rituximab) for diseases such as rheumatoid arthritis and non-Hodgkin's lymphoma.

Rixathon is approved for non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Clearance was based on a comprehensive development programme showing biosimilarity of Rixathon to MabThera, including the ASSIST-RA study, which demonstrated no clinically meaningful differences in safety, tolerability, or immunogenicity in patients with rheumatoid arthritis, and the ASSIST-FL study, which met its primary endpoint of equivalence in overall response rate.

MabThera/Rituxan pulls in sales of more than $7 billion a year across its indications. While pricing data for Rixathon are not yet available, Novartis says it expects its drug to “broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities”.

"Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years,” noted Carol Lynch, global head, Biopharmaceuticals, Sandoz.

Earlier this year, Celltrion bagged a regulatory approval for its biosimliar of the drug Truxima.

At the time, Professor László Gulácsi, head of Department of Health Economics, Corvinus University of Budapest, said budget savings across the 28 countries of the EU could be around 570 million euros in the first three years, assuming the price of biosimilar rituximab is 70 percent that of its reference product and that its market share is 30 percent, 40 percent and 50 percent over that time frame.

"This equates to 49,000 new RA, NHL and CLL patients who could be receiving life-changing treatment which is clearly a huge aggregate health-gain at both a national and EU level.”

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