STgen Bio, a subsidiary of Dong-A Socio Holdings, has strengthened its position in the global biosimilar market after its Songdo Bio Plant in Korea received approval from the U.S. Food and Drug Administration (FDA). The certification, announced on October 14, covers the facility’s drug substance and prefilled syringe manufacturing processes.
This FDA approval follows the European Medicines Agency’s (EMA) certification in September, enabling STgen Bio to commence commercial production of its Stelara biosimilar, DMB-3115, for both U.S. and European markets. The biosimilar, branded as Imuldosa, targets autoimmune diseases.
STgen Bio’s president, Choi Kyung-eun, highlighted the strategic importance of these approvals, stating they position the company as a reliable supplier for the world’s largest biopharmaceutical markets, including the U.S., Europe, and Japan.
While the company touts its enhanced competitiveness, industry observers note that STgen Bio faces stiff competition in the growing biosimilar sector. The firm’s ability to attract contracts from major pharmaceutical companies remains to be seen, as it seeks to capitalize on its newly acquired global manufacturing credentials.
