Latest news with #Celltrion
Korea Herald
4 days ago
- Business
- Korea Herald
Seoul shares open slightly lower on Trump tariff on copper, medicine
South Korean stocks started a tad lower Wednesday on US President Donald Trump's renewed tariff threats on copper and pharmaceuticals. The benchmark Korea Composite Stock Price Index shed 0.19 point, or 0.01 percent, to 3,114.76 in the first 15 minutes of trading. Trump announced plans to impose a 50 percent duty on copper imports and up to 200 percent tariffs on pharmaceuticals on Tuesday (US time), a day after he released letters sent to South Korea, Japan and other countries, detailing plans to impose reciprocal tariffs starting on Aug. 1. US stocks finished mixed. The Dow Jones Industrial Average fell 0.37 percent and the S&P 500 lost 0.07 percent, while the Nasdaq composite gained 0.03 percent. In Seoul, large caps opened in negative territory. Market bellwether Samsung Electronics dropped 1.3 percent, and chip giant SK hynix declined 1.42 percent. Drugmakers went south as Celltrion retreated 0.57 percent, and Samsung Biologics fell 0.39 percent. Top carmaker Hyundai Motor decreased 1.9 percent, and leading internet firm Naver lost 1.94 percent. However, leading retailer Lotte Shopping rose 2.89 percent, and instant noodle maker Samyang Food added 0.84 percent. The local currency was trading at 1,373.95 won against the US dollar at 9:15 a.m., down 5.95 won from the previous session. (Yonhap)
Korea Herald
5 days ago
- Business
- Korea Herald
Celltrion debuts denosumab biosimilars in US
South Korean biopharmaceutical firm Celltrion said Tuesday that it had released its denosumab biosimilars, Stoboclo and Osenvelt, in the US market, which is valued at approximately 9 trillion won ($6.5 billion). The biosimilars are approved for all indications of the original drugs, Prolia and Xgeva, after Celltrion secured full-label FDA approval in March and finalized a patent settlement with the original manufacturer. The products launched at a wholesale acquisition cost about 5 percent lower than the originals and will be distributed directly through Celltrion's US subsidiary. To support its market entry, Celltrion signed a supply agreement with a major US hospital group, ensuring product availability from the launch date. The company aims to rapidly expand its presence in the US 'open market,' which accounts for 30 percent of the denosumab segment and is less influenced by pharmacy benefit managers. The bio giant anticipates revenue growth for the release, as the original drugs, Prolia and Xgeva, generated a combined global revenue of approximately 9.2 trillion won in 2024 worldwide. 'Stoboclo-Osenvelt will expand treatment options for US patients while enhancing accessibility,' said Thomas Nusbickel, chief commercial officer of Celltrion USA. 'We're confident in our ability to scale prescriptions and secure share through both open market and PBM channels.'
Yahoo
5 days ago
- Health
- Yahoo
Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)
STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1],[2] STOBOCLO and OSENVELT, among the first wave of biosimilars referencing PROLIA and XGEVA respectively, are commercially available in the U.S. Celltrion further expands its portfolio, delivering cost-effective and high-quality biologic medicines to wider range of patients in the U.S. JERSEY CITY, N.J., July 7, 2025 /PRNewswire/ -- Celltrion USA today announced that STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively, are commercially available in the United States. STOBOCLO is available in 60 mg/mL injection and is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.[1] OSENVELT is available in 120 mg/1.7 mL (70 mg/mL) injection and is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.[2] "We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option. Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems." STOBOCLO and OSENVELT are supported by Celltrion's comprehensive patient support programs designed to help empower patients to navigate their treatment journeys. Celltrion offers a suite of resources, including the Celltrion CONNECT® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program. Patients who are uninsured may be able to receive STOBOCLO and OSENVELT at no cost. Visit and to learn more. Celltrion's biosimilars portfolio covers the areas of immunology, oncology, gastroenterology, allergy, and endocrinology. About STOBOCLO® (denosumab-bmwo) STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. INDICATIONS STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD. STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab. Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia. Drug Products with Same Active Ingredient: Do not use with other denosumab products. Hypersensitivity: If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis. Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO. Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop. Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur. Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops. Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes. Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products. Most common Adverse Reactions: In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. For more information, see Full Prescribing Information. About OSENVELT® (denosumab-bmwo) OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. INDICATION OSENVELT® (denosumab-bmwo) is indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. IMPORTANT SAFETY INFORMATION Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products. Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly. Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT. Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT. Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose. Most common Adverse Reactions: Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. For more information, see Full Prescribing Information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on our social media - LinkedIn. 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 also 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 to 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 associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by 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. Trademarks STOBOCLO® and OSENVELT® are registered trademarks of Celltrion, and XGEVA® are registered trademarks of Amgen Inc. References [1] STOBOCLO U.S. prescribing information (2025) [2] OSENVELT U.S. prescribing information (2025) US-CT-P41-25-00006 For further information please contact:Andria Arenaaarena@ 516-578-0057 View original content to download multimedia: SOURCE Celltrion Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Korea Herald
20-06-2025
- Business
- Korea Herald
[Bio USA] Celltrion deepens global ties, unveils R&D vision at Bio USA
BOSTON — Korean biotech company Celltrion showcased its expanded vision as a next-generation drug developer at Bio USA this week, using the global stage in Boston to deepen ties with international partners and explore cutting-edge biotech collaborations. According to Celltrion on Thursday, the company held more than 150 meetings over the four-day event, engaging in discussions with global pharmaceutical and biotech firms on a wide range of potential collaborations. Over 1,800 visitors stopped by Celltrion's booth during the convention, as announced by the company. Focusing on its core mission of "new drug development" this year, the company concentrated on exploring partnership opportunities to strengthen its pipeline in areas such as antibody-drug conjugates, multispecific antibodies, novel antibody drugs and peptides. The company also held extensive discussions on open innovation initiatives aimed at identifying promising technologies in drug development. Celltrion plans to closely review the meetings from Bio USA to identify potential partners with high growth potential and technical capabilities. In addition, the company said it engaged in wide-ranging talks about expanding its distribution network, receiving collaboration proposals from various companies for drug transportation, storage and other logistical support. Celltrion supplies its biosimilar products through direct sales channels in major global markets. For countries where it relies on indirect sales, the company actively held meetings to strengthen its existing distribution networks. Beyond business meetings, Celltrion also conducted promotional activities throughout the event, such as placing QR-coded brochures throughout its booth to highlight the company's key businesses and major products. Visitors who participated in surveys were offered custom keychains as part of a fun event to drive engagement. 'There was notable interest this year in Celltrion's expansion into the new drug development space,' a Celltrion official said. 'We are committed to securing the best technologies and potential partnerships to advance our pipeline of novel therapeutics. These efforts will reinforce Celltrion's capabilities as it grows into a major global pharmaceutical company.' Celltrion has participated in Bio USA for 16 consecutive years since 2010, continuously seeking global partnerships.
Yahoo
19-06-2025
- Business
- Yahoo
Celltrion opens new UK headquarters in Uxbridge, UK
New office located in the heart of Uxbridge underscores Celltrion's long-term business commitment in the UK LONDON, June 19, 2025--(BUSINESS WIRE)--Celltrion UK has officially opened its new UK headquarters at the Charter Building in Uxbridge, UK, reinforcing the company's dedication to long-term growth and partnership in the UK market. The opening ceremony was attended by Hyoung-Ki Kim, CEO and Vice Chairman at Celltrion, Rosalind Campion, Director of the Office for Life Sciences and Mark Samuels, Chief Executive of Medicines UK, and the British Biosimilars Association. The event was marked with a ribbon cutting ceremony. Strategically located in the heart of Uxbridge, the new office will serve as Celltrion UK's central hub for UK operations. This move places Celltrion among a growing list of life sciences companies including Regeneron, Amgen, Gilead Sciences, Daiichi Sankyo, that have established presence in Uxbridge – emerging as a leading hub for biotechnology and pharmaceutical innovation. Speaking at the opening ceremony, Hyoung-Ki Kim, CEO and Vice Chairman of Celltrion, said, "The opening our new UK office marks a pivotal milestone in Celltrion UK history. This demonstrates our strong commitment to the UK, a strategic market for our growth. We are here for the long term and are invested in the future of biosimilars in the UK. We look forward to continued collaboration with local institutions and regulatory bodies to ensure sustainable access to high-quality biologic treatments." Rosalind Campion, Director of the Office for Life Sciences, added, "With the NHS prescribing already 80% generic by volume, the next frontier is Biosimilars. This is a pivotal time for the sector just before the introduction of the life sciences sector plan and the NHS 10 year plan." Mark Samuels, chief executive of Medicines UK, said, "Celltrion's medicines are a critical part of the UK life sciences ecosystem, and I am delighted that the company is strengthening its investment in the UK with a new office, supporting British jobs and the supply of essential medicines for the NHS." The new headquarters also reflects continued growth for Celltrion UK, which has expanded its headcount by 20% over the past year. With an exciting pipeline of new products spanning across multiple therapeutic areas including allergy, endocrinology, ophthalmology and immunology anticipated over the coming years, the company expects further recruitment and investment in the coming years. This move is the latest chapter in Celltrion's long-term vision for the UK, demonstrating its dedication to being a trusted healthcare partner, a contributor to the UK economy, and a key player in the global biosimilars market. Notes to Editors: About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion Healthcare UK Limited (Celltrion UK) Celltrion UK is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the Medicines and Healthcare products Regulatory Agency (MHRA) regulations. For more information, please visit: 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 results expressed or implied by such forward-looking 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. View source version on Contacts For further information please contact: Donna Gandhidgandhi@ +44 (0) 203 817 6591
