Celltrion said Tuesday it has picked Switzerland-based Lonza to manufacture its autoimmune biosimilar Remsima’s drug substance at a Singapore facility.
Lonza is a global contract development and manufacture organization headquartered in Basel.
“Demand for biosimilars are soaring worldwide, and for a smooth and timely supply of products we have forged collaborative ties with Lonza,” said Celltrion CEO Woo Sung-kee.
Celltrion’s two plants in Songdo, South Korea, have a capacity to manufacture 190,000 liters of drug substances per year but the company is seeking to diversify its supplies.
“With Lonza’s quality management system and stable manufacturing capacity, Celltrion will expand its global supply base and secure price competitiveness through mass production,” Woo said.
In June 2018, Celltrion and Lonza agreed to partner for applications to European Medicines Agency and US’ Food and Drug Administration for the approval of Remsima drug substance manufactured at the Lonza plant in Singapore.
With the application to EMA completed based on the groundwork done in the first quarter of 2019, the two companies will now collaborate on filing an application to the US FDA.
Remsima manufactured at the Singapore plant will be supplied to European and American markets following approval.
Celltrion is considering further deals with Lonza for its products, such as its Leukemia treatment Truxima and breast cancer treatment Herzuma.
By Lim Jeong-yeo (email@example.com)