ARTICLE
19 April 2023

Celltrion Confirms Bioequivalence For CT-P39 Against Xolair In Interim Results Of Phase 3 Study

GP
Goodwin Procter LLP

Contributor

At Goodwin, we partner with our clients to practice law with integrity, ingenuity, agility, and ambition. Our 1,600 lawyers across the United States, Europe, and Asia excel at complex transactions, high-stakes litigation and world-class advisory services in the technology, life sciences, real estate, private equity, and financial industries. Our unique combination of deep experience serving both the innovators and investors in a rapidly changing, technology-driven economy sets us apart.
On April 10, 2023, Celltrion confirmed the bioequivalence of CT-P39 to treat allergic asthma and chronic urticaria, through its interim results from its global phase 3 clinical trials at 24 weeks.
United States Intellectual Property
To print this article, all you need is to be registered or login on Mondaq.com.

On April 10, 2023, Celltrion confirmed the bioequivalence of CT-P39 to treat allergic asthma and chronic urticaria, through its interim results from its global phase 3 clinical trials at 24 weeks. CT-P39 is a biosimilar referencing Xolair (ingredient: omalizumab), which is an antibody biopharmaceutical that treats allergic asthma, chronic urticaria, and chronic rhinosinusitis. Xolair's substance patent has already expired and the formulation patent is set to expire in March 2024 in Europe and November 2025 in the U.S. Celltrion said that it "plans to complete the remaining phase 3 studies of CT-P39 and file for product license in Korea and key other countries later this year."

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More