News | September 3, 2019

Celltrion And Lonza Sign Contract To Manufacture Remsima Drug Substance

  • Celltrion contracts Remsima drug substance manufacturing to Lonza to satisfy increasing global demand for biosimilars
  • Lonza’s biologics facility in Singapore to cover EU and US market needs
  • Partnership will provide cost-effective biologics for greater patient benefit worldwide

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.[1]

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. 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.

“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,” said Marc Funk, CEO, Lonza Group. “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.”

About Celltrion
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in the research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA and Remsima, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.

About Lonza
Lonza is an integrated solutions provider that creates value along the Healthcare Continuum. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.

​ Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.​

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. For more information, visit www.lonza.com.

[1] Therapeutic Indications approved by the EMA and the FDA: Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Pediatric Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasi.

SOURCE: Celltrion