Reported about 1 year ago
Following the approval of the first biosimilar drug in Taiwan by the US FDA, Tai Fu-KY has submitted biologic biosimilar product TX05 for re-evaluation to the FDA on July 8th, 2024, aiming to target the $1.1 billion US market annually. TX05, Tai Fu's second self-developed biosimilar drug referencing Herceptin, completed its Phase III clinical trials in February 2021, demonstrating safety, immunogenicity, and efficacy equivalence to the reference drug. With experience in biosimilar development and FDA compliance, Tai Fu's CDMO business also shows promising growth prospects with two potential clients in advanced negotiation stages.
Source: YAHOO