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Celltrion applies for FDA approval of anticancer biosimilar

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Celltrion applies for FDA approval of anticancer biosimilar

The U.S. Food and Drug Administration (FDA) has accepted Celltrion’s application to win the approval for its biopharmaceutical product for the treatment of blood cancer and rheumatoid arthritis, an antibody biosimilar Truxima (ingredient name: rituximab).

In April, Celltrion announced it had submitted to FDA documents related to Truxima’s approval concerning all its indications, including rheumatoid arthritis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia, and filed a formal application…

Fuente: Korea Biomedical Review

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