CELLTRION
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
Picsart and Zazzle Power the Creator-to-Commerce Evolution with Print-On-Demand Integration17.12.2025 20:47:00 CET | Press release
Partnership Gives Creators an End-to-End Solution to Create A Range of Products in the $205 Billion Creator Economy Picsart, the world’s leading digital creation platform with over two billion downloads and more than 100 million monthly active users, is partnering with Zazzle, the global leader in customized products and designs, to deliver an end-to-end printing solution for Picsart users. The new “vibe-design-to-print” integration works seamlessly with Picsart’s recently expanded suite of AI products, including AI Assistant and Flows, enabling creators to ideate, iterate, design, and bring their work to life as physical art and products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251217882832/en/ Picsart and Zazzle Power the Creator-to-Commerce Evolution with Print-On-Demand Integration “At Picsart, our mission has always been to give creators the tools they need to bring their ideas to life,” said Hovhannes Avoyan, Fo
Inspiring Leadership Recognised: Anna Byrne Named Finalist at CIPD 2026 HR Awards17.12.2025 19:58:00 CET | Press release
ProAmpac, a global leader in flexible packaging and material science, is proud to announce that Anna Byrne has been selected as a finalist in the “Most Inspirational and Impactful Leader” category at the CIPD 2026 HR Awards in Ireland. This recognition highlights Anna’s exceptional leadership, her unwavering commitment to people-first practices, and her meaningful influence across the organisation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251217690526/en/ The CIPD HR Awards in Ireland The CIPD HR Awards highlight the people profession’s crucial role in driving strategy, leading transformation, and enabling organisations to thrive. Overseen by CIPD Ireland and supported by independent academic expertise, the awards celebrate innovation, integrity, and impact within modern HR practice. This year, the awards introduce four new categories, including the “Most Inspirational and Impactful Leader” award, reflecting the evolvi
GeologicAI Announces Acquisition of Lumo Analytics to Complete Its Integrated Sensor Suite Across Critical Minerals and Rare Earth Elements17.12.2025 17:53:00 CET | Press release
GeologicAI, the global leader in High-Resolution Decision Engineering for the critical minerals sector, today announced its acquisition of Lumo Analytics, a provider of the most compact and efficient Laser-Induced Breakdown Spectroscopy (LIBS) scanner in the market. LIBS is a rapid, non-destructive technique that uses a high-energy laser pulse to vaporize a tiny spot on a rock, creating a short-lived plasma which emits light unique to the elements present when it cools. This spectral “fingerprint” provides immediate chemical information about the material. For the mining sector, this means faster geochemical insights directly at the source, enabling more efficient exploration and resource evaluation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251217715846/en/ The transaction firmly cements GeologicAI’s position as the only truly comprehensive and integrated source of sensor data for the critical minerals industry. Buildi
Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma17.12.2025 17:20:00 CET | Press release
Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab is the first CD19- and CD20-dual-targeted immunotherapy combination regimen approved for eligible patients in Europe with relapsed or refractory FLPatients with relapsed or refractory FL achieved significantly improved progression-free survival with Minjuvi in combination with rituximab and lenalidomide in the Phase 3 inMIND registration trialIn Western countries, including Europe, relapsed or refractory FL affects 2-4 out of every 100,000 people1 Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy. "The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL,” said Bi
Rigaku Launches ONYX 3200, a Metrology Instrument for Semiconductor Manufacturing17.12.2025 16:00:00 CET | Press release
Enables complete metal inspection for all processes from chip wiring to advanced packaging on a single platform Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; hereinafter “Rigaku”) announced the launch of the ONYX 3200, a new semiconductor metrology system to measure film thickness, composition and bump* structures for wafer-level processes. The system is engineered to help manufacturers stabilize quality and increase yield in the metal-wiring formation (back-end-of-line (BEOL)) and packaging processes of semiconductor chips. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216597402/en/ ONYX 3200 Due to accelerating demands for AI, high-performance computing, data centers, mobile devices, and other devices, chip wiring and interconnect structures have grown increasingly delicate and complex. As a
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