Celltrion obtains approval of Steqeyma from FDA

The company will sell the biosimilar of the autoimmune disease treatment Stelara in February 2025 in the US

Celltrion obtains approval of Steqeyma from FDA
Jeong Min Nam 1
2024-12-18 15:57:46 peux@hankyung.com
Bio & Pharma

South Korea's Celltrion Inc. said on Wednesday it received new drug submission (NDS) approval from the Food and Drug Administration (FDA) for Steqeyma (ustekinumab) in the US, the biosimilar of autoimmune disease treatment Stelara.

Based on the global Phase 3 results, Celltrion can sell Steqeyma in the US for psoriasis vulgaris, psoriatic arthritis, Crohn's Disease, and Ulcerative Colitis.

Celltrion got Steqeyma's approval in South Korea, Europe, the UK, Canada, and other countries before the US. The company is in the process of rolling out the product.

Celltrion expects to finalize a patent settlement with the original drug developer of Steqeyma to enter the US market in February next year. 

Write to Jeong Min Nam at peux@hankyung.com
#Celltrion #FDA #approval #Steqeyma #biosimilar #autoimmune disease treatment #Stelara

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