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.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.