Tanvex BioPharma (Tanvex-KY) announced on the 25th that its biosimilar drug NYPOZI—referenced to the original granulocyte colony-stimulating factor Neupogen—has officially launched in the U.S. market through Invagen Pharmaceuticals, Inc., a subsidiary of its American sales partner Cipla. Tanvex’s San Diego facility is also actively expanding production capacity, with two additional 2,000-liter bioreactors expected to come online in Q1 2026.

Tanvex BioPharma stated that this product is manufactured at scale at its San Diego facility, making Tanvex the first Taiwanese company to successfully bring a biosimilar to the U.S. market. Moreover, Tanvex is Taiwan’s first biologics CDMO to have passed U.S. FDA inspections, possess local commercial-scale manufacturing capabilities, and gain hands-on experience in successfully launching products in the U.S.

According to the licensing, sales, and manufacturing agreement signed in June 2025 with U.S. sales partner Cipla, Cipla will handle marketing and sales of NYPOZI in the U.S., while Tanvex BioPharma, as the registered manufacturing facility, will be responsible for large-scale production and supply. Tanvex will generate commercial returns through product supply revenue, royalties, milestone payments, and post-launch sales sharing. The first batch of NYPOZI was shipped from Tanvex’s San Diego facility in September and delivered to Cipla for subsequent marketing and sales in the U.S.

Resource: 泰福生物相似藥 在美上市