FDA Issues CRL to Novartis’ Sandoz for Proposed Roche Biosimilar

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Sandoz, the generics arm of Novartis, regarding the company’s biologics license application (BLA) for its proposed biosimilar to Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases. Rituxan had 2017 global sales of CHF 7.3 billion ($7.8 billion).

Sandoz says it is currently evaluating the content of the letter. “Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter,” the company said in a May 2, 2018 statement. “While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.”

In June 2017, the European Commission approved Sandoz’s biosimilar of Rituxan in all indications. This was the second biosimilar approval for Rituxan in 2017. In February 2017, Celltrion Healthcare, the marketing, sales, and distribution arm of Celltrion, an Incheon, South Korea-based pharmaceutical company, also received approval from the EC for Truxima (rituximab), another biosimilar to Roche’s Rituxan. 

Source: Novartis

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