Tanvex Submits BLA for Proposed Filgrastim Biosimilar

Tanvex BioPharma, a Taiwan-based biopharmaceutical company, announced this week the submission of its Biologics License Application (BLA) to the FDA for TX-01, a proposed filgrastim biosimilar referencing Neupogen.

Click here to read more about biosimilar filgrastim.

Tanvex announced that it would be seeking the same indications for TX-01 as the reference product is currently approved for: the treatment of chemotherapy-induced neutropenia. According to data from IQVIA, filgrastim sales for Neupogen, Zarxio, and Granix combined were estimated to be $700 million in the United States last year, and Tanvex hopes to capture a share of that market.

“The submission of the BLA for TX-01 represents an exciting milestone for Tanvex. Such a remarkable action takes Tanvex one step closer to launching its very first biosimilar product in the [United States] market,” said Allen Chao, MD, CEO of Tanvex Biopharma.

Tanvex is also in the midst of developing 3 other biosimilars: TX-05, a proposed trastuzumab biosimilar, referencing Herceptin, is currently beginning phase 3 trials for the treatment of HER2-positive breast cancer; TX-16, a potential bevacizumab biosimilar, referencing Avastin, is nearing the conclusion of phase 1 trials and is being investigated for the treatment of metastatic colorectal cancer; and TX-17, a proposed adalimumab biosimilar, referencing Humira, is still in the preclinical phase and is being developed to treat patients with rheumatoid arthritis.

To date, there are 2 filgrastim biosimilars available for use in the United States: Zarxio and Nivestym, the latter of which just recently came to market at a 30.3% discount to the reference product. Though there is a third filgrastim on the market, tbo-filgrastim, sold as Granix, it is not technically a biosimilar due to the fact that it earned FDA approval prior to the creation of the biosimilar approval pathway.