FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sandoz Walks Away From Rituxan Biosimilar in the U.S.

Nov. 13, 2018
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Novartis subsidiary Sandoz abandoned its pursuit of U.S. approval for its biosimilar of Roche’s blockbuster cancer drug Rituxan (rituximab) and said it plans to focus on other products in the biosimilar pipeline.

Sandoz secured European approval in June 2017 for its biosimilar Rixathon, marketed in Europe as Mabthera. But the FDA sent Sandoz a complete response letter in May 2018 regarding the biosimilar, for which the drugmaker was seeking indications to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and autoimmune diseases.

At the time of the CRL, Sandoz said it “stands behind the robust body of evidence” contained in its NDA and committed to continued talks with the FDA to secure approval. But last week, Sandoz announced it was ditching the effort after the agency requested more information.

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