Celltrion Reaches US Patent Agreement with Johnson & Johnson on Stelara Biosimilar

Stellara Biosimilar 'CT-P43'
Agreed for Release on March 7, 2025

Celltrion announced that it has finalized a patent agreement in the United States for the Stelara biosimilar 'CT-P43' with Johnson & Johnson (J&J), the parent company of Janssen, the developer of the autoimmune treatment 'Stelara' (active ingredient ustekinumab).

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

According to this agreement, CT-P43 developed by Celltrion will be able to enter the U.S. Stelara biosimilar market starting March 7, 2025, upon obtaining U.S. approval. Celltrion completed the application for CT-P43 approval with the U.S. Food and Drug Administration (FDA) in June, aiming for product approval next year.

The original drug of CT-P43, Stelara, developed by Janssen, is an interleukin (IL)-12 and IL-23 inhibitor used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The substance patent for Stelara is set to expire in the U.S. this September and in Europe in July 2024.

Since the U.S. is considered the largest global market for ustekinumab, Celltrion expects that once sales begin, it will play a significant role in expanding its influence in the autoimmune disease treatment market. They also added that expanding their portfolio to include interleukin inhibitors, in addition to the previously launched TNF-α (tumor necrosis factor) inhibitor Remsima, will strengthen their competitiveness in the autoimmune disease treatment market.

According to IQVIA, a global pharmaceutical market research firm, the global ustekinumab market size in 2022 reached $17.713 billion (approximately KRW 23.0269 trillion). Among this, the U.S. market accounted for about 77% of the total, with $13.628 billion (approximately KRW 17.7164 trillion).

A Celltrion official stated, "Celltrion has been smoothly negotiating with the original drug developer to enable early sales of CT-P43 immediately after approval, and this patent agreement has made the U.S., the largest market for ustekinumab, a visible target. We will do our best to proceed with the remaining approval procedures without delay and to introduce CT-P43 to the market as soon as possible."

Meanwhile, Celltrion has set a goal to apply for approval within this year for five biosimilars: Stelara, Eylea, Xolair, Prolia, and Actemra. Currently, approval applications have been completed for three products: Stelara and Xolair ('CT-P39' in Europe and domestically), and Eylea ('CT-P42' in the U.S.). Prolia (CT-P41) and Actemra (CT-P47) are finishing Phase 3 clinical trials, with plans to complete approval applications within this year.

This content was produced with the assistance of AI translation services.