Celltrion’s Remsima (infliximab), a biosimilar to Johnson & Johnson’s Remicade, is approved for the treatment of conditions such as rheumatoid arthritis, Chron’s disease, and ulcerative colitis.
The biosimilar is available after being approved by both the European Commission (EC) and US Food and Drug Administration (FDA), becoming the first monoclonal antibody to receive approval from the US agency.
According to the joint release by Lonza and Celltrion, the level of demand has meant that the latter company has had to tap into the former’s capacity for drug product production – despite Celltrion’s 190,000L capacity.
A spokesperson for Lonza confirmed that it would make a portion of its 20,000L capacity available to Celltrion, without confirming exact numbers.
Lonza will produce the additional drug product from its commercial facility based in Singapore.
The two companies confirmed that they had worked together on the validation process at the facility, and had already applied to the European Medicines Agency (EMA) for approval of products produced at the site. The companies will seek further approval from the FDA in due course.
Regarding the EMA approval process, Lonza’s spokesperson told us, “[The] Singapore site has already been approved for manufacturing several biologics in multiple regions, including Europe and the US, and is ready to support Celltrion in its regulatory process as needed.”
Part of the reason given for the partnership agreement was the benefit of establishing a diversified supply base for a product.
Lonza’s spokesperson outlined why this would be attractive, “The challenge for our customers is to anticipate and maintain flexibility to meet the evolving global demand for their products.”
They continued, “Increasing demand for biosimilars depends on many different aspects, so having different manufacturing sites allows for a more flexible supply, addressing the changing market dynamics and complementing our customers manufacturing network.”
