News | January 16, 2019

Tanvex Submits NDS For TX01 To Health Canada

Back on November 2018, the US Food and Drug Administration (FDA) accepted Tanvex BioPharma’s Biologics License Application (BLA) for TX-01 (filgrastim), a proposed biosimilar to the reference product Neupogen (filgrastim) which is indicated for chemotherapy induced neutropenia. Recently, Tanvex BioPharma, Inc. is proud to also announce its New Drug Submission (NDS) to the Health Canada for filgrastim.

According to IMS data, filgrastim product sales (including Neupogen and Grastofil) were over $100M(USD) in the Canada for the 12 months ending November 30, 2018.

“This additional filing confirms our support into the biosimilar market and strategy to explore additional opportunities that improve affordability and access to high quality biologics”, said Dr. Allen Chao, CEO of Tanvex BioPharma, Inc.

About Tanvex
Tanvex BioPharma, Inc. is a biopharmaceutical company focused on the biosimilar market. The Company is vertically integrated with end-to-end in-house development, manufacturing and commercialization capabilities.

Source: Tanvex BioPharma, Inc