Tanvex BioPharma Secures Asia’s First FDA Approval for Filgrastim Biosimilar, Seizing a $403 Million Market

On June 29th, Taipei time, Tanvex BioPharma, headquartered in Taiwan, announced that the U.S. Food and Drug Administration (FDA) granted market approval for their biosimilar drug TX01, which treats neutropenia by stimulating white blood cell production. This approval marks Taiwan’s debut in the U.S. biosimilar market. It also represents Tanvex BioPharma’s first market authorization and the first FDA approval for a biosimilar drug from Taiwan, as well as the first FDA approval for a filgrastim biosimilar in Asia.

US FDA-approved Facilities and cGMP Strengthen Tanvex’s Commercialisation and CDMO Services

Chen, Lin-Cheng, Chairman and CEO of Tanvex BioPharma, emphasized that obtaining FDA market approval represents a significant milestone for the company. In addition to internally developing biosimilar drugs, Tanvex BioPharma has commenced offering contract development and manufacturing organization (CDMO) services for biologics. The company has gained extensive experience from developing cell lines to undergoing FDA inspections and securing subsequent BLA market approvals. By operating FDA-approved facilities adhering to current good manufacturing practice (cGMP) standards in the United States, Tanvex BioPharma has strengthened its competitiveness in both product commercialization and CDMO services.

Now, Tanvex markets its biosimilar drug TX01 under the name Nypozi, referencing the originator drug Neupogen (filgrastim). It is approved for treating neutropenia induced by cancer chemotherapy. This approval represents the fourth and latest FDA approval for a filgrastim biosimilar, following Kashiv Biosciences’ Releuko in February 2022, Pfizer’s Nivestym in July 2018, and Sandoz’s Zarxio in March 2015.

Filgrastim products, which are recombinant human granulocyte colony-stimulating factors, stimulate neutrophil proliferation and maturation, aiding their release into the blood. These products are approved for various indications to reduce the risk of febrile neutropenia, a life-threatening condition linked to chemotherapy.

The Filgrastim Biosimilar Market Valued at $403 Million

According to IQVIA data as of March 2024, the U.S. filgrastim market is valued at $403 million, with Canada following at $65 million. Nypozi debuted in Canada in January of this year. Althoug it had received US FDA approval in October 2021, the first applications for the drug to enter the US market did not meet with success until now. Initially, Tanvex submitted its application for the filgrastim biosimilar candidate TX01 to the US FDA in October 2018, but faced rejection in September 2019. Tanvex subsequently addressed concerns, including those related to COVID-19 pandemic restrictions affecting FDA site inspections, among others, ultimately securing FDA market approval.

This approval marks a significant achievement for Tanvex BioPharma and Taiwan’s biotechnology sector, showcasing the country’s innovation in biopharmaceuticals. Tanvex BioPharma continues its dedication to advancing biologics research and manufacturing, aiming to provide advanced treatment options globally. Major players in the filgrastim biosimilars market include Cadila Pharmaceuticals, Dr. Reddy’s Laboratories, Intas Biopharmaceuticals, Sandoz, Amgen Inc., Intas Pharmaceuticals, Emcure Pharmaceuticals Ltd, and Tanvex.

The filgrastim biosimilar market employs two main manufacturing approaches: companies either produce them in-house or contract with manufacturing organizations (CMOs) or CDMOs. CMOs offer comprehensive services to pharmaceutical firms on a contractual basis, covering drug discovery through to production. Filgrastim biosimilars serve a versatile range of applications, including oncology, chronic and autoimmune diseases, blood disorders, growth hormone deficiency, and infectious diseases. These products reach patients through multiple channels such as hospital pharmacies, retail pharmacies, and online platforms.

Taiwan’s Global Pharmaceutical Reach

Ten drugs originating from Taiwan are currently marketed overseas, encompassing Nephoxil, ONIVYDE, Trogarzo, Taigexyn, Besremi, Naldebain, Fespixon/Bonvadis, Camcevi, Nypozi, and Tascenso ODT. The journey from initial market approval to achieving substantial sales typically spans four to six years, excluding the extended regulatory review periods and associated licensing and distribution expenses. These drugs cover a spectrum of therapeutic areas and are pivotal in Taiwan’s growing prominence in the global pharmaceutical market.

This approval signifies Taiwan’s entry into the U.S. biosimilar market, marking Tanvex BioPharma’s inaugural market authorization and Taiwan’s first FDA approval for a biosimilar drug. Additionally, it represents Asia’s first FDA approval for a filgrastim biosimilar. Essentially, Tanvex BioPharma’s FDA approval marks a significant milestone for Taiwan’s biopharmaceutical industry, highlighting its innovation and entry into global markets. Alzheimer’s disease, Brominated vegetable oil, Donanemab, Lilly, Eli Lilly and Company, fda alzheimer’s drug, kisunla, fda approves alzheimer’s drug, new fda approved alzheimer’s drug, kisunla drug, fda approval, what is fda, fda guidance, fda approves

Reference: Official Information

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Author

Bernice Lottering