Celltrion reaches patent agreement for Stelara biosimilar CT-P43

Celltrion headquarters in Incheon [CELLTRION]

Celltrion reached a patent agreement for its copycat drug of Stelara, a blockbuster psoriasis treatment by Janssen Pharmaceuticals, with Janssen’s parent company Johnson & Johnson (J&J).

With the agreement settled, Celltrion will be able to sell CT-P43, a biosimilar candidate referencing Janssen’s top-selling drug Stelara, in the U.S. market starting March 7, 2025, if the U.S. regulator grants the Songdo, Incheon-based company a sales approval.

Celltrion filed for marketing approval for CT-P43 in the United States with the U.S. Food and Drug Administration in June.

Stelara is the brand name for the ustekinumab drug. Stelara’s patent protection is currently expected to expire in September in the United States and July 2024 in the European nations.

However, Janssen may retain its U.S. market exclusivity for some time as J&J recently settled with Amgen as well as other two biosimilar drug makers. This settlement, announced in May, allows Amgen to begin selling the copycat version of Stelara in the United States “no later than Jan. 1, 2025.”

The United States is the largest market for the ustekinumab drug. The global ustekinumab market size reached $17.7 billion in 2022, with the U.S. revenue representing some 77 percent of the total with $13.6 billion, according to market tracker Iqvia.

“The latest patent agreement opens the door for us to the United States, the biggest market for ustekinumab,” a Celltrion spokesperson said.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]