Prestige BioPharma’s Manufacturing Facility for Trastuzumab Biosimilar Receives EU-GMP Certification

Prestige BioPharma has announced that the manufacturing facility for Tuznue, a proposed trastuzumab biosimilar, has received European Union (EU) Good Manufacturing Practices (GMP) certification. A statement from Prestige BioPharma described the EU-GMP certification as “one of the highest standards of pharmaceutical production in the world,” one that gives companies a path to bring therapies to market in Europe.

Tuznue, which references Roche’s Herceptin, can be used to treat HER2+ breast and metastatic gastric cancer and has been evaluated in a phase 3 trial. The therapy is currently under review for marketing authorization by the EU European Medicines Agency, Canada, and South Korea.

According to the statement, Prestige Biopharma’s research pipeline includes biosimilars and first-in-class therapies, including biosimilars referencing Avastin and Humira.

“EU-GMP certification of our manufacturing arm in Korea demonstrated our global standard biomanufacturing facility and system that are applied to all of our products,” said

Lisa S. Park, CEO of Prestige BioPharma. “By achieving one of the key requirements for product registration, we are one step closer to global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need.”