Celltrion, Claiming '11 Similar Products by 2025'... First Goal on Track

Goal to Commercialize 11 Products by 2025
Declaration of 5 Approval Applications and 2 Clinical Trials Initiated Within the Year

Achieved 40% of Goal with CT-P43 Approval Application
Reached Half of Goal with CT-P53 Clinical Trial Approval

CELLTRION, which has set a goal to commercialize a total of 11 products by 2025 by adding 5 new products to the existing 6, is steadily taking steps toward this goal. So far, among the 5 products targeted for approval application this year and 2 pipelines entering clinical trials, approval applications for 2 products have already been completed, and clinical trials are progressing rapidly for the first pipeline, the biosimilar of 'Ocrevus'.

On the 15th, CELLTRION submitted the marketing authorization application for the autoimmune disease treatment 'Stelara' (active ingredient ustekinumab) biosimilar ‘CT-P43’ to the Korean Ministry of Food and Drug Safety, and on the same day (local time), announced that it received approval from the U.S. Food and Drug Administration (FDA) for the Phase 3 clinical trial plan (IND) of 'CT-P53', a biosimilar of Ocrevus (active ingredient ocrelizumab), a treatment for multiple sclerosis.

The marketing authorization application for CT-P43 covers all indications of the original drug Stelara, including Crohn's disease and ulcerative colitis. CELLTRION had previously applied for approval of CT-P43 to the European Medicines Agency (EMA) last month and plans to submit the application to the FDA soon.

The original drug Stelara, of which CT-P43 is a biosimilar, is an interleukin (IL)-12 and IL-23 inhibitor developed by Janssen (a subsidiary of Johnson & Johnson). It is a blockbuster product used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. According to IQVIA, a global pharmaceutical market research firm, the global ustekinumab market size reached $17.77 billion (approximately 22.633 trillion KRW) last year.

Once CT-P43 receives domestic approval, CELLTRION expects to strengthen its competitiveness in the domestic autoimmune disease treatment market by expanding its portfolio to include interleukin inhibitors in addition to the existing tumor necrosis factor (TNF)-alpha inhibitor products such as 'Remsima IV', 'Remsima SC', and 'Yuflyma'.

Currently, CELLTRION has completed approval applications for two of the five biosimilars targeted for approval this year?Stelara and Xolair ('CT-P39' in Europe). It plans to submit the marketing authorization application for the Aflibercept biosimilar 'CT-P42' to the FDA within the first half of the year, and aims to complete approval applications for Prolia (CT-P41) and Actemra (CT-P47) after finishing Phase 3 clinical trials within this year.

Meanwhile, among the two pipelines set for clinical trial initiation this year, the Ocrevus (active ingredient ocrelizumab) biosimilar CT-P53, which recently began clinical procedures, marked a smooth start by receiving IND approval from the FDA on the same day (local time).

This approval came about one month after submitting the global Phase 3 IND application to the FDA on the 15th of last month. CELLTRION has also submitted an IND to the EMA. The clinical trial will involve a total of 512 patients with relapsing-remitting multiple sclerosis, comparing the efficacy, pharmacokinetics, and safety between CT-P53 and Ocrevus.

Ocrevus is a blockbuster autoimmune disease treatment developed by Roche. As of last year, it generated sales of 6.036 billion Swiss francs (approximately 9 trillion KRW), ranking first in the global multiple sclerosis market. It is used to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Its patent is expected to expire in the U.S. in 2029. So far, only Polpharma in Poland has announced plans to develop a biosimilar, and since it is still in the early development stage, CELLTRION expects to be the 'first mover' in this market.

A CELLTRION official stated, “CT-P43 has confirmed equivalent efficacy and safety compared to the original drug through global Phase 3 clinical trials,” adding, “We will proceed sequentially with approval procedures in major global markets following Europe and Korea to ensure that high-quality biopharmaceuticals are supplied to patients.” The official continued, “With the clinical approval of the new pipeline CT-P53 in the U.S., we have begun full-scale clinical procedures and are preparing to target the U.S. ocrelizumab market worth over 6 trillion KRW. We will accelerate Phase 3 clinical trials to become the first mover in the Ocrevus biosimilar market.”