CELLTRION
24.5.2024 03:27:31 CEST | Business Wire | Press release
Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®. Omlyclo® is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).
The EC approval of Omlyclo® follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024.
The decision is based on clinical evidence, including results from a global Phase III clinical trial designed to evaluate the efficacy, safety and pharmacokinetics of Omlyclo® compared to the reference product Xolair® in patients with CSU up to Week 40.
“For more than two decades, omalizumab, a blockbuster monoclonal antibody anti-IgE, has revolutionised the management of chronic immune-mediated inflammatory diseases,” said Professor Marcus Maurer, Professor of Dermatology and Allergy, Co-Director for the Fraunhofer Site for Immunology and Allergology of the Fraunhofer Translational Medicine and Pharmacology ITMP and Executive Director for the Institute of Allergology, Charité - Universitätsmedizin Berlin, Germany. “The development of a biosimilar of omalizumab is a welcome solution to help alleviate some challenges with treatment access. The recently approved treatment Omlyclo® has a comparable efficacy, safety and immunogenicity profile to Xolair®.”
“Immunological conditions such as asthma can have a significant impact on the day-to-day lives of patients without appropriate treatment and care. This is why we are pleased to receive the first EC approval for an omalizumab biosimilar in Europe, an important step towards improving patient access to treatment. As we continue to expand our biosimilar offerings across the globe, building on our immunology and oncology product portfolio, we look forward to making a meaningful difference for patients living with immunological conditions,” said Hyoung-Ki Kim, Vice Chairman at Celltrion.
Omlyclo® is Celltrion’s sixth biosimilar, besides Remsima® SC, a subcutaneous formulation of infliximab, approved for use in the EU, following the approval of Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), and Vegzelma® (biosimilar bevacizumab). Omlyclo® is currently under review by the U.S. Food and Drug Administration (FDA), following the submission in March 2024.
About OMLYCLO® (CT-P39, biosimilar omalizumab)
Omlyclo® is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). In the EU, Omlyclo® is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).
About Celltrion
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima® and Herzuma®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma® and Yuflyma®, FDA approval for Zymfentra™, and EC approval for Remsima® SC. To learn more, please visit www.celltrion.com/en-us.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion Inc. and its subsidiaries believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
Trademark
Xolair® is a registered trademark of Novartis AG.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240521556727/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Phenom Adds Major Headline Speakers as IAMPHENOM Europe Approaches Sold-Out Status6.10.2026 15:30:00 CEST | Press release
Second wave of esteemed speakers to bring real-world guidance on applying AI, agents and automation to improve hiring, development and retention Phenom, the leader in applied AI built to redesign work operations for hiring faster, developing better and retaining longer, today announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006714151/en/ Phenom announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. The two-day conference gives attendees what other HR events can’t: an inside look at AI agents already in production, automated workflows tailored to specific business contexts and the dramatic results they are already delivering. Across keynotes, customer
European Firms Struggle to Keep Pace with Growing DSAR Demands, New Reveal Study Finds6.10.2026 15:00:00 CEST | Press release
With 86% of organisations still lacking dedicated DSAR technology, fewer than half of requests are completed within the one-month window GDPR requires, even as spending climbs New research published today byReveal, the provider of integrated AI-native platforms spanning the dispute resolution lifecycle, found that large European organisations complete fewer than half of data subject access requests (DSARs) within the one-month deadline required under the General Data Protection Regulation (GDPR), a shortfall the study ties directly to a near-universal absence of purpose-built technology. Nearly nine in 10 organisations still run DSARs on manual or general-purpose workflows, with no dedicated tooling in place. The report, based on a survey of 213 legal and privacy professionals at large European enterprises, is the first of its kind to benchmark how organisations across the region are managing DSAR compliance at scale. The findings expose structural inconsistencies between how organisat
New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support6.10.2026 15:00:00 CEST | Press release
Rimini Street and DBTA/Unisphere Research survey finds 66% are already using or are considering third-party support Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced findings from the 2026 IT Virtualization Survey – What’s Next for VMware Users, a new global survey of nearly 300 VMware user organizations conducted by Unisphere Research on behalf of Rimini Street. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006014490/en/ New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support Cost Cited as the Number One Factor in Seeking Alternative VMware Solutions Key Findings: 90% of respondents said they are considering alternatives to VMware due to higher licensing costs, while 54% cited the end of perpetual license supp
Xsolla Shows Brand Owners How to Create Value for Video Players at Brand Licensing Europe With Rewarded Marketing6.10.2026 15:00:00 CEST | Press release
Twenty-One Years of Game Commerce Comes to ExCeL London, October 6 to 8, With a New Way for Brands to Reward the Players They Have Been Trying to Reach for Years Xsolla, a global commerce company, today announced it will be at Brand Licensing Europe 2026 at ExCeL London, October 6 to 8, to show brand owners how to engage with video game players by creating quest-based programs and value new users actually value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006443167/en/ Graphic: Xsolla Video games are one of the largest categories of entertainment spending in the world, yet most brands still treat the category as an experiment: a one-off promotional stunt or a single media buy, not a lasting engagement program. The traditional formats brands default to were never built for players. Interstitial pop-ups disrupt gameplay, banner ads go unnoticed, and in-game activations remain cumbersome and expensive to execute. The idea
Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets6.10.2026 15:00:00 CEST | Press release
Europe and the Americas join Rochester's growing global e-commerce network Rochester Electronics today announced the launch of fully enabled e-commerce capabilities across its regional websites, allowing customers in key global markets to search for, source, and purchase authorized semiconductors in their local language. While Rochester's regional sites previously offered localized content and product information, they now support a complete end-to-end purchasing experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006914131/en/ Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets The newly upgraded platforms are now live in Portuguese (Brazil), Spanish (Mexico), French, German, Italian, and Polish, complementing Rochester’s existing full e-commerce platforms in English, Chinese, Japanese, and Korean (South Korea). Customers can now complete transactions directly through their lo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom