Celltrion and Lonza Sign Contract to Manufacture Remsima Drug Substance

Celltrion and Lonza announced a contract manufacturing agreement to produce drug substance for Remsima, a biosimilar approved by the EMA and the FDA for a number of autoimmune diseases including Crohn’s disease and rheumatoid arthritis.

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.