Reported 12 months ago
On June 30, 2024, at 9:13 PM, TaiGen Biotechnology's biosimilar drug TX01 received approval from the U.S. Food and Drug Administration (FDA). This marks TaiGen's entry into the largest biosimilar drug market in the world, the United States, with the first biosimilar drug approved by the FDA in Taiwan under a BLA (Biologics License Application). Not only is this TaiGen's first market approval, but it's also Taiwan's first FDA-approved biosimilar drug and Asia's first FDA-approved filgrastim biosimilar drug for white blood cell growth. This milestone signifies TaiGen's transition into a comprehensive biopharmaceutical company, with added services extending to outsourcing the development and manufacturing of biopharmaceuticals.
Source: YAHOO