- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
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.
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
