Celltrion gets approval of Steqeyma from FDA

Quick Summary:

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

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Category: Economy

Markets: South KoreaCanada

Topics: Korea Approval Baby South Shark Steqeyma Disease Global Celltrion Drug Cookies

Source Website Secure: Yes (HTTPS)

News Sentiment: Neutral

Fact Checked: Legitimate

Article Type: News Report

Published On: 2024-12-18 @ 15:57:46 (4 hours ago)

News Timezone: GMT +8:00

News Source URL: kedglobal.com

Language: English

Article Length: 112 words

Reading Time: 1 minutes read

Sentences: 11 lines

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Copyright Owner: © Korea Economic Daily

News ID: 24532688

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