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
Enginzyme and AGC Create Scalable Process for Key mRNA Ingredient12.1.2026 06:00:00 CET | Press release
At the mRNA Health conference in Berlin, enginzyme and AGC Inc. presented a scalable process to produce a key mRNA vaccine and therapy ingredient, N1-methylpseudouridine-5'-triphosphate (m¹ΨTP). The rapid growth of mRNA-based vaccines and therapeutics has driven significant demand for modified nucleotides like m¹ΨTP, which enhances mRNA stability and expression, while reducing immunogenicity. Enginzyme is a deep-tech company delivering optimized biomanufacturing solutions through cell-free enzyme engineering technology. AGC Inc. is a leading global player in fields spanning from architectural glass to chemicals and life science. AGC Inc. provides services in a wide range of life science fields, from synthetic pharmaceuticals and agrochemicals, to biopharmaceuticals and leading-edge cell and gene therapies, as well as messenger RNAs. The presentation in November detailed the latest collaboration between the companies, with a focus on the biomanufacturing of nucleotides for mRNA therapy,
Ant International Partners with Google’s Universal Commerce Protocol to Expand AI Capabilities12.1.2026 02:15:00 CET | Press release
Ant International, a leading global payment, digitisation, and financial technology provider, is collaborating on the launch of Google’s Universal Commerce Protocol (UCP), a new open standard for agentic commerce that works across the entire shopping journey — from discovery and buying to post-purchase support. UCP establishes a common language for agents and systems to operate together across consumer surfaces, businesses, and payment providers to enable commerce. So instead of requiring unique connections for every individual agent, UCP enables all agents to interact easily. UCP is built to work across verticals and is compatible with existing industry protocols like Agent2Agent (A2A), Agent Payments Protocol (AP2), and Model Context Protocol (MCP). “For agentic commerce to scale, it’s critical for the industry to align on a common set of standards. We are proud to have Ant International endorse the Universal Commerce Protocol as the foundation for that future,” said Ashish Gupta, VP
Torq Secures $140M Series D at $1.2B Valuation to Lead the AI SOC and Agentic AI Era11.1.2026 17:59:00 CET | Press release
Fueled by Massive Customer Adoption of AI Agents, Torq Scales the World’s First True AI SOC Platform and Accelerates Expansion into the U.S. Federal Market Torq, the established Agentic AI security operations pioneer, today announced it has closed a massive $140 million Series D funding round, propelling its valuation to $1.2 billion and total funding to $332M. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112510774/en/ Led by Merlin Ventures—a leading cybersecurity fund renowned for its deep access to the U.S. commercial and Public Sector markets—with participation from all existing investors, including Evolution Equity Partners, Notable Capital, Bessemer Venture Partners, Insight Ventures Partners, and Greenfield Partners, this capital injection is a definitive investment in the future of security. Torq is driving the industry’s critical shift: the complete transformation of the Security Operations Center (SOC) through
Andersen udvider sine kompetencer med tilføjelsen af Scimitar9.1.2026 21:44:00 CET | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Scimitar, der er et firma med fokus på at accelerere innovation i biovidenskabsbranchen. Scimitar, der har hovedkvarter i USA, et førende konsulenthus inden for strategieksekvering for biovidenskabsbranchen. Virksomheden er specialiseret i design af driftsmodeller, digital transformation og organisatorisk forandring. Scimitar samarbejder med medicinal- og biotech-virksomheder om at accelerere innovation, styrke den driftsmæssige eksekvering og sikre compliance gennem hele produkters livscyklus. Deres praktiske og samarbejdsorienterede tilgang sikrer løsninger, der ikke blot er formålstjenlige, men også skalerbare. "Virksomheder inden for biovidenskabsbranchen befinder sig i en tid med hurtige videnskabelige fremskridt, stigende regulatorisk kompleksitet og et voksende behov for operationel agilitet, samtidig med at de holdes op mod de højeste standarder for patientsikkerhed og dataintegritet," udtaler Ramy Khalil, CEO i Scimitar.
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 13:00:00 CET | Press release
Expanded collaboration builds on Acepodia and Biocytogen’s recent co-development efforts to evaluate selected bispecific antibody and dual-payload ADC programs Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreem
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