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
Samsung and Mistral AI Announce Strategic Partnership for Intelligence-Driven Semiconductor Infrastructure8.9.2026 18:15:00 CEST | Press release
Collaboration will focus on development and implementation of on-premises AI technologies across Samsung’s chip operationsSamsung makes lead investment in Mistral’s funding round Samsung Electronics Co., Ltd., today announced it has entered into a strategic partnership with Mistral AI to enhance its semiconductor engineering and manufacturing capabilities that will reinforce its leadership in AI chip technologies. The announcement of the partnership was made during the state summit held in Paris between South Korea and France. Under the agreement, Samsung will integrate Mistral’s AI services and solutions—including its flagship large language model, Mistral Large—across its semiconductor operations to develop customized on-premises AI models optimized for intelligence-driven infrastructure. Mistral’s powerful AI platform is expected to provide Samsung with a unique stack of tools that will transform how semiconductors are designed and manufactured. The on-premises enterprise solutions
Sensereo Airo Wins IFA Berlin Innovation Award8.9.2026 17:00:00 CEST | Press release
Prestigious Accolade Recognizes Sensereo’s Next-Generation Approach to Creating Healthier, Smarter Indoor Environments Sensereo, an environmental intelligence company developing next-generation sensing products for safer, healthier and smarter living, was presented with the prestigious IFA Berlin Innovation Award for its Airo modular indoor air quality system. The award was presented during IFA Berlin on Thursday, Sept. 4, recognizing Airo for its innovative approach to helping consumers better understand and manage the quality of their indoor environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260906292649/en/ Winner of a 2026 IFA Innovation Award, Airo is Sensereo’s flagship environmental intelligence platform, combining advanced sensing technology with a modular design that allows users to monitor multiple aspects of indoor air quality and environmental conditions through a single, consumer-friendly system. Desig
Verdantis Rebrands as the AI Super-Agent for MRO, Sets Sights on AI-Native Enterprise Asset Management8.9.2026 16:06:00 CEST | Press release
Nine AI agents now run the MRO decision chain for Fortune 500 plants; new tagline “Anticipate. Resolve. Learn.” Verdantis, the AI company for spare parts and MRO inventory optimization in asset-intensive industries, today unveiled its new brand identity as the AI Super-agent for MRO and announced it is building toward a fully AI-native Enterprise Asset Management (EAM) platform. Verdantis’s super-agent orchestrates nine specialized AI agents across the decisions that decide plant uptime: spare parts, criticality, demand, reorder, and work order planning. These decisions set working capital, maintenance spend, and whether a critical asset runs and, in most plants, they are still made in spreadsheets and disconnected systems. The positioning is for the teams who own uptime - maintenance, reliability, and MRO supply chain leaders in oil and gas, mining, utilities, chemicals, and manufacturing. And it reflects an AI-first architecture: agents decide and act by default; people supervise, ov
HyperLight Welcomes VentureTech Alliance to Series C, Deepening TFLN Integration Across the Semiconductor Ecosystem8.9.2026 16:00:00 CEST | Press release
HyperLight Corporation ("HyperLight"), a leader in thin-film lithium niobate (TFLN) photonics, today announced that VentureTech Alliance ("VTA") has joined its Series C financing round. VTA is a venture investment firm focused on the semiconductor industry, with a portfolio built across the semiconductor technology stack — including circuit design, foundry-adjacent process technology, EDA, advanced packaging, and photonics. VTA's participation extends the ecosystem alignment that defined the round, which brought together investors spanning silicon ICs, foundry manufacturing, electronics manufacturing services, networking, and global infrastructure capital. With VTA's addition, the syndicate now reaches further into the semiconductor manufacturing and design-enablement layers on which high-volume photonics production depends. "The transition to TFLN is not a component decision — it is an ecosystem decision," said Mian Zhang, CEO of HyperLight. "Getting TFLN into volume requires the proc
EcoOnline Appoints Conor O’Loughlin as CEO8.9.2026 16:00:00 CEST | Press release
O’Loughlin brings founder, product and commercial experience spanning startup growth, global SaaS scale and M&A EcoOnline, a global provider of software that transforms how organisations protect people and the planet, today announced the appointment of Conor O’Loughlin as Chief Executive Officer, effective immediately. O’Loughlin succeeds Tom Goodmanson and will lead the Company into its next chapter of growth and innovation, continuing EcoOnline’s mission of keeping employees safe across the globe and supporting more than 11,000 customers. O’Loughlin is an experienced, growth-oriented technology operator and founder. He co-founded fitness technology company Glofox, scaling it into a global SaaS business serving customers in more than 80 countries before its acquisition by ABC Fitness in 2022. Following the acquisition, he served as Platform President and later Global Chief Revenue Officer at ABC Fitness, leading strategy across the company’s revenue-generating activities. “Keeping peo
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