Remsima is a biosimilar version of Remicade. The drug (infliximab) is a monoclonal antibody used to treat a range of autoimmune conditions including inflammatory bowel disease and rheumatoid arthritis. Infliximab was initially marketed in the US as Remicade by Johnson & Johnson where it reached prices as high as US$19,000 per month.

Celltrion’s Remsima was the first biosimilar monoclonal antibody treatment to be approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). It has since been approved in almost 80 different countries across the globe.

Celltrion’s two plants in South Korea have the capacity to manufacture 190,000 litres of drug substance per year. To meet rising demand for Remsima, Celltrion reached out to CMOs to help produce the product.

In early September 2019, Celltrion announced a contract with Lonza to manufacture Remsima at a facility in Singapore. Treatment produced at the plant will be supplied to European and American markets.

Celltrion CEO Woo Sung-Lee commented: ‘Demand for biosimilars are soaring worldwide, and for a smooth and timely supply of products we have forged collaborative ties with Lonza. With Lonza’s quality management system and stable manufacturing capacity, Celltrion will expand its global supply base and secure price competitiveness through mass production’.

Mark Funk, CEO of the Lonza Group, said they will be working closely with Celltrion to give the company access to its ‘flexible capacity and agile teams’ to help them meet 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’, he added.

However, the companies still need EMA and FDA approval for Remsima produced at the Lonza plant. Applications to EMA are complete and the two companies will now collaborate to file an application to FDA. Celltrion is reportedly also considering working with Lonza for production of its leukaemia treatment Truxima (rituximab) and breast cancer treatment Herzuma (trastuzumab).

Also, Celltrion has established a unit in Ireland in order to expand across the European biosimilars market. The unit, Celltrion Biopharma, was established in May 2019, where Celltrion plans to conduct clinical trials of its biosimilars and prepare for sales in Europe.

The firm has recently completed a phase III clinical trial for a subcutaneous version of Remsima (Remsima SC) [1], which is a pen-type formulation allowing patients to inject the treatment themselves without the need to visit a hospital. Remsima SC is awaiting approval from EMA to allow sale in Europe.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Phase III trial for subcutaneous Remsima completed [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 4]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-for-subcutaneous-Remsima-completed

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