To complement its existing capacity of 190,000L of drug substance per year from two plants in Korea, Celltrion has looked to Lonza to diversify its supply base and meet the increasing demands of the biosimilar market.
The Remisma drug substance will be produced in Lonza’s commercial facility in Singapore to cover market needs in Europe and North America. Over the first quarter of 2019, the two companies worked together on the validation process at Lonza’s Singapore manufacturing facility and have submitted the products produced there for approval by the European Medicines Agency (EMA). Continuing the collaboration, the two companies will also seek Food and Drug Administration (FDA) approval.
“The stable manufacturing system and superb product quality management were the most important factors in choosing our partner Lonza,” said Woo Sung Kee, chief executive officer, Celltrion. “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.”
Marc Funk, chief executive officer, Lonza Group, said, “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. In the competitive biosimilars market, we can support Celltrion with our experience in biologics as it enables broader patient access to affordable, life-changing therapies.”