FDA setback for Sandoz' proposed biosimilar rituximab

3 May 2018

The US Food and Drug Administration has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for Sandoz’ proposed biosimilar rituximab.

Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis (NOVN: VX), says it stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible, the company stated.

Rituximab is the cancer and autoimmune diseases drug marketed by rival pharma giant Roche (ROG: SIX) as Rituxan in the USA and MabThera in Europe, and generated first-quarter 2018 sales of 1.71 billion Swiss francs ($1.73 billion), down 8% on the like period of 2017.

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