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
Robbyant Releases LingBot-Touch to Bring General-Purpose Touch Perception to Robots10.11.2026 10:23:00 CET | Press release
Robbyant, an embodied AI company within Ant Group, today announced the open-source release of LingBot-Touch, a tactile foundation model that gives robots a critical missing sense by enabling robust touch perception. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109284905/en/ LingBot-Touch encodes magnetic tactile, visual tactile, and piezoresistive signals into unified tactile tokens for use by different action models. Pre-trained on nearly 5,000 hours of real-world tactile data, the model covers three mainstream sensing modalities—magnetic tactile, visual tactile, and piezoresistive sensing—and translates their diverse signals into a unified tactile representation. This allows different dexterous hands and action models to share and reuse tactile understanding, enabling robots to not only “see clearer” and “think deeper,” but also “feel sharper” during fine manipulation tasks, such as turning pages, unscrewing bottle ca
Wise Selects Navan to Modernize Global Travel Program10.11.2026 10:00:00 CET | Press release
Global financial technology company plans to improve traveler choice, cost control and visibility Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced that Wise (Nasdaq:WSE, LSE:WISE), the global financial technology company building the best way to move and manage the world's money, has selected Navan to manage its business travel program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109603155/en/ Global financial technology company plans to improve traveler choice, cost control and visibility “Our teams travel across the world to work together and support our customers, so it's important that booking and managing travel is straightforward,” said Hanro Hennig, VP Global Real Estate, Workplace and Risk at Wise. “We're working with Navan to make that experience simpler, while giving us better visibility and control over travel costs.” Key anticipated benefits of the partnershi
Quectel Launches EG216Q-GL and BG950Q-GL to Give IoT Device Makers a More Cost-efficient, Lower-power Upgrade Path10.11.2026 10:00:00 CET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced the EG216Q-GL and BG950Q-GL, two next-generation global cellular IoT modules based on Qualcomm technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110650568/en/ Quectel launches EG216Q-GL and BG950Q-GL to give IoT device makers a more cost-efficient, lower-power upgrade path Built in Quectel’s widely adopted EG2 and BG95 form factors, the modules give device makers a direct route from established legacy platforms to a more cost- and power-optimized generation. Customers can reuse the board designs and development work they already have. The EG216Q-GL is an LTE Cat 1bis module for customers whose designs use Quectel’s EG2-footprint modules. These include the EC2x series, EC200A series, EG25-G, EG25-GL, EG21-G and EG21-GL, as well as the UC200A-GL. Because it shares their form factor, manufacturers can upgrade while keeping their
Heitman Partners with Talliosake to Establish Nordic Drive-Up Self-Storage Platform Talli10.11.2026 10:00:00 CET | Press release
Since 1996, Heitman has invested over $15 billion in 1,600 self-storage properties across 14 countries Heitman LLC (“Heitman”), a global real estate investment management firm, today announced the launch of Talli, a new Nordic drive-up self-storage platform established through the acquisition of the majority of Talliosake Oy’s (“Talliosake”) rental operating business. Talliosake will remain a minority investor in Talli. Completed on behalf of Heitman’s European value strategy, the transaction establishes a platform for expansion across Finland and Sweden and builds on Heitman’s Nordic self-storage presence following its acquisition of the Servistore platform in Sweden in 2024. The Talli platform brings together the experienced management team that has driven Talliosake’s growth with Heitman’s global investment and operational capabilities. Since 2010, Talliosake has delivered more than 6,400 drive-up self-storage units across 230 properties in Finland and Sweden, building deep expertis
OBI Group Will Adopt Blue Yonder Solutions to Unify Demand Planning and Replenishment Across 660+ European Stores10.11.2026 09:00:00 CET | Press release
Germany-based Home and Garden retailer replaces multiple systems with a single AI-driven planning platform spanning 10 countries OBI Group, a leading European Home and Garden retailer, has begun adopting Blue Yonder Demand Planning and end-to-end replenishment capabilities across its stores and distribution centers, with plans to ultimately deploy them to more than 660 stores across all of its markets. The deployment replaces multiple systems with a single, scalable platform. It also gives OBI AI-enabled forecasting and automated replenishment from distribution centers to store shelves, improving product availability for millions of customers across Europe. OBI selected Blue Yonder to consolidate fragmented planning systems into one integrated platform. That helps improve forecast accuracy across assortment types and planning timeframes while standardizing forecasting and replenishment processes across its network. Blue Yonder’s machine-learning capabilities and the prospect of future
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