FDA Approves Biosimilar, But it Comes with a Severe Label Warning

Truxima is the first FDA-approved biosimilar to Roche’s blockbuster drug for non-Hodgkin’s lymphoma.

Celltrion / Image: Kim Hong Ji
Celltrion / Image: Kim Hong Ji

A November 28th Reuters article reported the approval of Celltrion Inc’s Truxima, the first biosimilar to Roche’s Rituxan. The move is part of the FDA’s plan to encourage competition to drive prescription prices down. To date, the FDA has approved 14 other biosimilars, including clones of blockbuster drugs like Humira and Neulasta.

The approval of Truxima was no surprise, since the drug achieved unanimous recognition from an FDA advisory panel in October. Its label contains the harshest form of a boxed warning that highlights several health risks including liver damage and a rare form of serious brain infection. Truxima is already approved in Europe, and will sold in the U.S. and Canada in partnership with Teva Pharmaceutical. Novartis has abandoned plans to gain FDA approval of its Rituxan biosimilar in the wake of the news.

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