Celltrion's large-scale production facility is the 1st cGMP Facility approved by US FDA in Asia
With 190,000L total production capacity, the Celltrion's large-scale production facility is the first Asian cGMP Facility approved by US FDA back in 2007. Recent GMP approvals of the facility were in 2018 by US FDA, EMA and PMDA. Celltrion has successfully launched biosimilar products around the world with rapid market share growth. Available real-world evidence has demonstrated efficacy and safety of the products.
1. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7(4):3 (eCollection 2018 Mar.)
2. D. Suh, S. Lee, and D. Suh, "PCN69 - Budget Impact of Substituting Biosimilar Trastuzumab (CT-P6) in Treating Gastric Cancer and Breast Cancer in 28 European Countries," Value Health, Vol. 21, P. S25, Oct. 2018.
3. Budget Impact Analysis of Trastuzumab Biosimilar CT-P6 on HER2+ Breast Cancer and Gastric Cancer Treatment in China, IQVIA and Vcell, 2019