Blog Big Molecule Watch January 23, 2019

Tanvex’s New Drug Submission for Filgrastim Biosimilar to Health Canada

Last October, we reported that Taiwan-based Tanvex BioPharma (“Tanvex”) announced that it had submitted a BLA to the FDA seeking approval of TX-01, a proposed biosimilar referencing Neupogen® (filgrastim) indicated for chemotherapy induced neutropenia. Last November, the FDA accepted Tanvex’s BLA for its filgrastim biosimilar. This week Tanvex has submitted a New Drug Submission (NDS) to Health Canada, quoting product sales (including Neupogen® and Grastofil®) of over US$100 million in Canada for the 12 months ending on November 30, 2018.

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