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

BioSimilars Patent Dance

BioSimilars Patent DanceLast 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.