Celltrion announced Tuesday that the company has submitted its application for marketing authorization to the European Medicines Agency for CT-P47, a biosimilar referencing Roche's Actemra.
Roche's Actemra (tocilizumab) is approved for a wide range of uses, including rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and cytokine release syndrome.
Celltrion’s application has been based on the results from a global phase three clinical trial, involving 471 patients with rheumatoid arthritis. The company said the results demonstrated CT-P47’s equivalence and similarity to the original Actemra in treating rheumatoid arthritis.
“Celltrion has completed the submission of the marketing authorization application for CT-P47 now both in the US and Europe to expand our autoimmune disease portfolio,” an official from Celltrion said.
If CT-P47 is approved in the US and Europe, the company will be able to add an interleukin inhibitor to its portfolio and strengthen its position in the global autoimmune disease treatment market. Previously, Celltrion had mainly introduced TNF-alpha (tumor necrosis factor-alpha) inhibitors, such as Remsima, to the global market.
Celltrion expects the biosimilar will be able to boost the company’s sales in the future as well. The global market for Actemra was estimated at around $2.8 billion in 2022, according to IQVIA, a drug market research firm.
Celltrion will also prepare for both subcutaneous and intravenous formulations of CT-P47 to increase the accessibility of the drug, it added.
After the US and Europe, Celltrion plans to submit its applications to other major countries, including Canada. “Celltrion will continue its discussions with regulatory authorities in other countries to accelerate the remaining approval processes and increase its supply of the treatment in the global market soon,” the official said.
Meanwhile, Celltrion aims to expand its biosimilar portfolio to 11 products by 2025 and 22 by 2030, targeting annual sales of 12 trillion won ($9 billion).
