Celltrion to release Stelara biosimilar in US from March 2025

South Korean biopharmaceutical company Celltrion Inc. announced on Friday that it has completed a patent agreement with Johnson & Johnson, the multinational pharmaceutical company that owns Janssen, in relation to the biosimilar drug Stelara (active ingredient: Ustekinumab) used for autoimmune diseases within the US. 

As a result of this agreement, Celltrion's Stelara biosimilar, known as CT-P43, will be able to enter the market starting from March 7, 2025, following its approval in the US.

The company submitted an application for approval to the US Food and Drug Administration (FDA) in June of this year, with the goal of obtaining product approval next year.

Stelara is a therapeutic agent developed by Janssen for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The substance patents for Stelara are set to expire in the US in September this year and in Europe in July next year.

Considering that Celltrion already has Remsima entering the US market, the introduction of CT-P43 is expected to strengthen its competitive position.

Write to Ji-Hyun Lee at bluesky@hankyung.com