Celltrion has looked to Lonza to diversify its supply base and meet the increasing demands of the biosimilar market to complement its existing capacity of 190,000 L of drug substance per year from two plants at its’ headquarters in South Korea. The contract manufacturing agreement centres around the production of a drug substance for Remsima at these facilities.
Woo Sung Kee, CEO of Celltrion, said: “It will be a great opportunity to expand our global supplying capacity to provide the greater healthcare benefit through these cost-effective biologics since demand of biosimilars is increasing worldwide.”
The drug substance will be produced in Lonza’s commercial facility in Singapore to cover market needs in Europe and the US. Over the first quarter of 2019, the two companies worked together on the validation process at the facility and have submitted the products produced there for approval by the EMA. Continuing the collaboration, the two companies will also seek US FDA approval.
Remsima is a biosimilar approved by the EMA and the FDA for a number of autoimmune diseases including Crohn’s disease and rheumatoid arthritis.
Marc Funk, CEO of the Lonza Group: “We will be working in close partnership with Celltrion to ensure it has access to the flexible capacity and agile teams it needs to respond to evolving market demand for Remsima.”
