Celltrion said on Friday that it finalized a U.S. patent settlement with Johnson & Johnson (J&J), for Celltrion’s Stelara (ingredient: ustekinumab) biosimilar, CT-P43.

Accordingly, the agreement allows Celltrion's CT-P43 biosimilar to enter the U.S. biosimilar market as a first-in-class product on March 7, 2025, if approved by the FDA. 

J&J’s Stelara substance patents are set to expire in the U.S. in September of this year and in Europe in July 2024.

Celltrion completed a submission to the FDA to seek approval of CT-P43 in June with the goal of obtaining marketing authorization in 2024.

J&J is the parent company of Janssen, which is the developer of the original autoimmune therapy, Stelara. 

The original drug 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 U.S. is the world's largest market for ustekinumab, and once commercialized, it is expected to help Celltrion expand its presence in the autoimmune disease treatment market.

According to IQVIA, a global pharmaceutical market research organization, the global ustekinumab market is expected to reach $17.7 billion in 2022, with the U.S. market accounting for $13.6 billion, or about 77 percent of the total market.

In particular, the expansion of the portfolio to include interleukin inhibitors, in addition to the previously launched tumor necrosis factor-alpha (TNF-α) inhibitor Remsima, will further strengthen its global competitiveness in the autoimmune disease treatment market.

Remsima is Celltrion's biosimilar to Johnson & Johnson's original drug Remicade (ingredient: infliximab) which treats rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and, psoriasis in adult patients.

“We have been working amicably with the developer of the original drug to ensure that CT-P43 can be marketed as soon as possible after approval, and this patent settlement makes it possible to target the U.S. which is the largest market for ustekinumab," said an official at Celltrion.