Celltrion and Lonza Sign Contract to Manufacture Remsima Drug Substance

On Sept. 3, 2019, Celltrion and Lonza announced a contract manufacturing agreement to produce drug substance for Remsima (infliximab), a biosimilar referencing Remicade (infliximab), Johnson & Johnson’s top-selling drug with $5.3 billion in 2018 sales. Remsima is approved by the European Medicines Agency (EMA) and FDA for a number of autoimmune diseases including Crohn’s disease and rheumatoid arthritis.

Celltrion formed the deal with Lonza to complement its existing capacity of 190,000-L of drug substance per year from two plants in Korea and to diversify its supply base to meet increasing demand from the biosimilars market.

The Remisma drug substance will be produced in Lonza’s commercial facility in Singapore to cover market needs in Europe and North America. The two companies worked together on the validation process at Lonza’s Singapore manufacturing facility during the first quarter of 2019. They have submitted the products produced at that facility for approval by EMA. The partners will also seek FDA approval for products produced at the Singapore facility.

“The stable manufacturing system and superb product quality management were the most important factors in choosing our partner Lonza. 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,” said Woo Sung Kee, CEO, Celltrion, in a company press release.

“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,” added Marc Funk, CEO, Lonza Group, in the press release. “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.”

Source: Celltrion