Celltrion said Thursday that it has completed submitting a marketing authorization application for CT-P47, a biosimilar to Actemra (tocilizumab) for treating autoimmune diseases, to the Ministry of Food and Drug Safety (MFDS).

Celltrion is accelerating efforts to diversify the formulations of CT-P47.
Celltrion has applied for the marketing authorization of CT-P47 for the full-label indications of Actemra (European brand name: Roactemra) in Korea, such as rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA).

The filing is based on results from a global phase 3 clinical trial in 471 RA patients, which confirmed equivalence and similarity to the originator drug.

Based on these phase 3 clinical trial results, Celltrion plans to accelerate its marketing authorization application in Canada and other countries. The company has already submitted marketing authorization applications to the U.S. FDA and the European Medicines Agency (EMA).

Roche's Actemra is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein involved in causing inflammation in the body, generating global sales of about 2.63 billion French francs (4 trillion won).

The expected approval of CT-P47 will expand Celltrion's autoimmune disease portfolio to include interleukin (IL) and the TNF-α (tumor necrosis factor) inhibitor group, including Remsima-Yuflyma, and further strengthen its global presence. Celltrion's Stelara biosimilar, CT-P43, which the company applied for marketing authorization at home and abroad last year, is also an interleukin inhibitor.

Considering that Actemra is available in subcutaneous (SC) and intravenous (IV) formulations, Celltrion plans to launch CT-P47 in SC and IV formulations so that healthcare providers can prescribe it according to patient condition and convenience.

"We will continue striving to expand our autoimmune disease portfolio by completing the license application for CT-P47 in Korea, following the U.S. and Europe. We will keep working with regulatory authorities in each country to complete the remaining licensing process to bring high-quality biologics to patients in Korea and abroad as soon as possible," a Celltrion official said.

All told, Celltrion has completed filing for approvals for five pipeline products -- Stelara biosimilar CT-P43, Xolair biosimilar CT-P39, Eylea biosimilar CT-P42, Prolia biosimilar CT-P41, and Actemra biosimilar CT-P47 – and are winning their marketing authorization.

Celltrion aims to win approval for these pipelines by 2025, bringing the total number of biosimilar products to 11 in addition to the six already commercialized. By 2030, the company added that Celltrion plans to have 22 products and attain a 12 trillion won sales goal.

Source:- Celltrion