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
Forbes Includes Philip Morris International in Its Net Zero Leaders List4.5.2026 10:00:00 CEST | Press release
PMI ranks number 4, marking its fourth consecutive year of recognition for making significant strides toward reaching net zero carbon footprint goals Philip Morris International (PMI) (NYSE: PM) has been included once more in Forbes’ 2026 Net Zero Leaders1 list, recognizing its leadership and continued progress in advancing climate action across its global operations. The Forbes Net Zero Leaders list highlights U.S. publicly listed companies best positioned to achieve net zero emissions by 2050, based on measurable performance rather than commitments alone. Despite most companies aligning to a 2050 net zero horizon, PMI remains committed to reaching net zero by 2040, as set out in its Climate Transition Plan published in 2025. This aspiration reflects PMI’s confidence in collective progress, trust that ambition drives innovation, that policy will evolve to enable change, and collaboration will accelerate system‑wide transformation. Above all, it signals hope: that by acting early and h
Mobius Renewables Acquires Air Liquide’s Biogas Production Activities in the United States, France, Norway, and Sweden4.5.2026 08:45:00 CEST | Press release
Mobius Renewables today announced the closing of the acquisition of Air Liquide’s biogas production activities in the United States, France, Norway, and Sweden. The acquisition includes six operating landfill gas-to-RNG (Renewable Natural Gas) sites in the U.S., five operating farm waste sites in France, and a 51% interest in Redo Biosolutions with production and distribution assets across Norway and Sweden. The acquired portfolio will be a meaningful addition to Mobius Renewables (“the Company”), a global, vertically integrated low carbon fuels platform established in December 2025 by funds managed by IFM Investors to accelerate the development, production, distribution, and commercialization of RNG at scale across North America and Europe. The Company is headquartered in Houston, Texas with additional offices in the United States, France, Norway, and Sweden. With this transaction, the establishment of Mobius Renewables is complete, and GreenGasUSA and the acquired portfolio will oper
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease1.5.2026 23:28:00 CEST | Press release
Jakafi XR is a once-daily, film-coated, extended-release formulation of Jakafi®(ruxolitinib)Once-daily Jakafi XR was shown to provide consistent, day-long exposure comparable to twice-daily JakafiJakafi XR will be available for pharmacy orders by May 8 Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501334677/en/ “The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meetin
Barilla Hosts Surprise Formula 1® Family Reunion Dinner During Miami Race Weekend1.5.2026 18:08:00 CEST | Press release
Drivers and team members of Formula 1® were reunited with their loved ones during a night that also celebrated the new partnership between Barilla and the Visa Cash App Racing Bulls Formula 1® Team. A special invitation, a table, and a plate of pasta shared by people who are often apart. That’s all it took for Barilla to bring the spirit of togetherness to Miami during the opening day of the FORMULA 1® CRYPTO.COM MIAMI GRAND PRIX 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430832316/en/ Barilla hosts Arvid Lindblad, Mikaela Shiffrin, and Nico Rosberg with Chef Massimo Bottura at Torno Subito, where the Formula 1® community came together for a surprise dinner. Barilla, the Official Pasta Partner of Formula 1®, welcomed team members and their families to Torno Subito Miami, the restaurant by three-Michelin-starred Chef Massimo Bottura, with the kitchen led by Chef Bernardo Paladini, for an evening where engines wer
TIME Names Xenco Medical one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health1.5.2026 12:07:00 CEST | Press release
Time Magazine has named pioneering medical technology company Xenco Medical as one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health. Widely regarded as the most prestigious recognition in business and technology, being selected to the TIME100 List remains the most coveted accolade that a company can achieve globally. The TIME100 Impact Awards are given to only 5 recipients each year, making it the rarest of honors that a company can receive and a profound recognition of transformative, global impact. Xenco Medical was honored by Time as the sole recipient of the TIME100 Impact Award in Health in 2026, signifying its leading, global distinction in impact on healthcare. According to Time Magazine, the TIME100 Most Influential Companies list highlights “companies making an extraordinary impact around the world.” The honor bestowed by Time comes after Xenco Medical was named the 2025 Medical Device/ Diagnostics Company of the
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