FDA Approves First Non-Hodgkin's Lymphoma Biosimilar

Law360 (November 28, 2018, 6:26 PM EST) -- The U.S. Food and Drug Administration on Wednesday approved Celltrion and Teva’s version of the blockbuster cancer treatment Rituxan, marking the first biosimilar approved in the U.S. to treat non-Hodgkin’s lymphoma.

Celltrion Inc. and Teva Pharmaceutical Industries Ltd.'s Truxima is the first Rituxan biosimilar to receive the FDA's okay, but others are being developed by Pfizer Inc. and Novartis AG unit Sandoz Inc. The stakes are high, as Rituxan and its follow-up Gazyva have already brought in a combined $1 billion in 2018, on top of $4 billion in sales last year, according to their maker, Biogen Inc.

“The approval of...

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