Novartis scraps U.S. filing for biosimilar rituximab

Nov 05, 2018

Novartis International AG’s Sandoz division will abandon its quest to win U.S. approval for rituximab.  

The medication, which is a biosimilar of Roche’s Rituxan, has already been approved in the EU, Japan and Australia. But in May, Sandoz received a complete response letter from the FDA — an indication that the drug approval application would not fly in its current form. 

Rituxan has several indications including rheumatoid arthritis and non-Hodgkin Lymphoma, and raked in more than $4 billion in sales for Roche in 2016.  

Other rituximab biosimilars made by Teva Pharmaceuticals and South Korea’s Celltrion have already been recommended for approval by the FDA. 

Sandoz said it’s disappointed that it has to pull away from the FDA application process, and stated that the company would instead concentrate its efforts on biosimilars that treat the greatest unmet needs. 

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