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.

Celltrion USA今天宣布，STOBOCLO®（地诺单抗-bmwo）和OSENVELT®（地诺单抗-bmwo）分别参照PROLIA®（地诺单抗）和XGEVA®（地诺单抗）的生物类似药现已在美国上市销售。

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].

STOBOCLO 有 60 mg/mL 注射剂型，获批用于治疗骨折高风险的绝经后女性骨质疏松症，增加骨折高风险男性骨质疏松症患者的骨量，治疗骨折高风险男性和女性的糖皮质激素诱导的骨质疏松症，增加接受非转移性前列腺癌雄激素剥夺治疗的骨折高风险男性的骨量，以及增加接受乳腺癌辅助芳香酶抑制剂治疗的骨折高风险女性的骨量。[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].

OSENVELT有120 mg/1.7 mL（70 mg/mL）注射剂型，适用于预防多发性骨髓瘤患者的骨骼相关事件，以及实体瘤骨转移患者的骨骼相关事件；用于治疗无法手术切除或手术切除可能导致严重并发症的成人和骨骼成熟的青少年骨巨细胞瘤患者；以及用于治疗对双膦酸盐类药物治疗无效的恶性肿瘤相关的高钙血症。[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.

“我们很高兴与安进就我们的地舒单抗生物类似药达成了全球和解，”Celltrion美国公司首席商务官托马斯·努斯比克表示。“我们很自豪能够将我们的地舒单抗生物类似药引入美国市场，为患者和医疗专业人员提供一种有价值的新治疗选择。”

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.'.

基于我们在生物仿制药领域的强大传统，Celltrion 坚持致力于成为患者和医生的可信赖合作伙伴，同时为医疗保健系统的整体可持续性做出贡献。

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.

STOBOCLO 和 OSENVELT 得到了 Celltrion 全面患者支持计划的支持，该计划旨在帮助患者掌控自己的治疗过程。Celltrion 提供了一系列资源，包括 Celltrion CONNECT® 患者支持计划和 Celltrion CARES™ 共付援助计划。

Patients who are uninsured may be able to receive STOBOCLO and OSENVELT at no cost. Visit www.CelltrionConnect.com and www.CelltrionCares.com to learn more. .

未投保的患者可能能够免费获得STOBOCLO和OSENVELT。访问www.CelltrionConnect.com和www.CelltrionCares.com了解更多信息。

Celltrion's biosimilars portfolio covers the areas of immunology, oncology, gastroenterology, allergy, and endocrinology.

Celltrion的生物类似药产品组合涵盖免疫学、肿瘤学、胃肠病学、过敏和内分泌学领域。

About STOBOCLO® (denosumab-bmwo)

关于STOBOCLO®（地诺单抗-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..

STOBOCLO®（地诺单抗-bmwo）是一种参照PROLIA®（地诺单抗）的NF-κB配体受体激活剂（RANKL）抑制剂。STOBOCLO 60 mg/mL 注射剂已获得FDA批准，基于全面的数据和临床证据，确认其与PROLIA具有治疗等效性。在美国，STOBOCLO 被批准用于治疗骨折高风险的绝经后女性骨质疏松症，增加骨折高风险男性骨质疏松症患者的骨量，治疗骨折高风险男性和女性的糖皮质激素诱导的骨质疏松症，增加接受非转移性前列腺癌雄激素剥夺疗法的骨折高风险男性的骨量，以及增加接受乳腺癌辅助芳香酶抑制剂治疗的骨折高风险女性的骨量。

Indications

适应症

STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment:

STOBOCLO®（地诺单抗-bmwo）是一种RANK配体（RANKL）抑制剂，适用于治疗：

Important Safety Information

重要安全信息

Warning: Severe Hypocalcemia in Patients With Advanced Kidney Disease

警告：晚期肾病患者严重低钙血症

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.

晚期慢性肾病患者，包括接受透析的患者，在使用地诺单抗后面临严重低钙血症的更高风险，已有报道称此类病例导致住院、危及生命的情况以及死亡。

The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients

慢性肾脏病-矿物质骨病（CKD-MBD）的存在显著增加了这些患者低钙血症的风险。

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.

在晚期慢性肾病患者开始使用STOBOCLO®（地诺单抗-bmwo）之前，应评估CKD-MBD。治疗应由有诊断和管理CKD-MBD经验的医疗保健提供者监督。

STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab.

STOBOCLO禁用于低钙血症、孕妇以及已知对地诺单抗过敏的患者。

Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia.

严重低钙血症：确保充足的钙和维生素D；监测严重低钙血症。

Drug Products with Same Active Ingredient: Do not use with other denosumab products.

具有相同活性成分的药品：请勿与其他地诺单抗产品同时使用。

Hypersensitivity: If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO.

超敏反应：如果发生过敏性休克或其他具有临床意义的过敏反应，应开始适当的治疗并停止进一步使用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.

颌骨骨坏死 (ONJ)：接受STOBOCLO治疗的患者可能会发生ONJ。治疗前进行口腔检查；保持口腔卫生；若发生ONJ，考虑停用STOBOCLO。

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.

非典型的股骨转子下骨折和骨干骨折：监测大腿、髋部或腹股沟疼痛；评估是否存在骨折。在进行个体化的获益-风险评估后，应考虑暂停STOBOCLO治疗。

Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO.

停止治疗后多发性椎体骨折 (MVF)：停用地诺单抗后风险增加；如果停止使用STOBOCLO，应过渡到替代疗法。

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.

严重感染：地舒单抗使用者风险较高；评估获益-风险概况，尤其是免疫功能低下的患者。在开始使用STOBOCLO之前评估获益-风险概况，如果出现严重感染，应重新考虑是否继续使用。

Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur.

皮肤病不良反应：如果出现严重的皮炎、湿疹或皮疹，应考虑停用STOBOCLO。

Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops.

肌肉骨骼疼痛：如果出现严重疼痛，考虑停用STOBOCLO。

Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes.

骨转换抑制：在绝经后骨质疏松症女性的临床试验中，地诺单抗显著抑制了骨重塑；应监测患者的这些结果。

Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products.

儿科患者骨质疏松症患者的高钙血症：不适用于儿科；据报道，使用地诺单抗产品的骨质疏松症患者出现高钙血症。

Most common Adverse Reactions:

最常见的不良反应：

For more information, see Full Prescribing Information.

有关更多信息，请参阅完整处方信息。

About OSENVELT® (denosumab-bmwo)

关于OSENVELT®（地诺单抗-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..

OSENVELT®（地诺单抗-bmwo）是一种NF-κB配体受体激活剂（RANKL）抑制剂，参考自XGEVA®（地诺单抗）。OSENVELT 120 mg/1.7 mL（70 mg/mL）注射剂已基于一项强有力的临床试验和全面数据获得FDA批准，确认了其与XGEVA的治疗等效性。在美国，OSENVELT适用于预防多发性骨髓瘤患者的骨骼相关事件以及实体瘤骨转移患者的骨骼相关事件；用于治疗无法手术切除或手术切除可能导致严重并发症的成人和骨骼成熟的青少年骨巨细胞瘤患者；以及用于治疗对双膦酸盐类药物耐药的恶性肿瘤相关高钙血症。

Indication

适应症

OSENVELT® (denosumab-bmwo) is indicated for:

OSENVELT®（地诺单抗-bmwo）适用于：

Important Safety Information

重要安全信息

Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products.

禁忌症：患有低钙血症或对地诺单抗产品有已知临床显著过敏反应的患者。

Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly.

具有相同活性成分的药物产品。接受OSENVELT治疗的患者不应同时接受其他地诺单抗产品。

Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT.

超敏反应。如果发生过敏性休克或其他具有临床意义的过敏反应，应开始适当的治疗并停止进一步使用OSENVELT。

Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake.

低钙血症。严重低钙血症可能会发生，并且已有致死病例报告。监测钙水平以及钙和维生素D的摄入。

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.

颌骨骨坏死 (ONJ)：接受OSENVELT治疗的患者可能会发生ONJ。在治疗前和治疗期间进行口腔检查并采取适当的预防性牙科措施；保持口腔卫生，避免侵入性牙科手术；若发生ONJ，考虑停用OSENVELT。

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.

非典型股骨转子下骨折和骨干骨折：监测大腿、髋部或腹股沟疼痛；评估是否存在骨折。应根据个体情况，在权衡利弊后考虑暂停奥塞韦尔特（OSENVELT）治疗。

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..

在骨巨细胞瘤患者和骨骼生长患者中，停药后可能出现高钙血症。在停止使用地诺单抗后的1年内，骨巨细胞瘤患者或骨骼生长患者可能会出现具有临床意义的高钙血症，可能需要住院治疗；停药后应监测血清钙水平，并管理钙和维生素D的需求。

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT.

停止治疗后多发性椎体骨折（MVF）。停止使用地诺单抗后风险增加；停止使用OSENVELT后评估椎体骨折风险。

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.

胚胎-胎儿毒性。地诺单抗可能对胎儿造成伤害；在开始使用奥森维尔特之前确认妊娠状态，并建议在治疗期间及最后一剂后5个月内采取有效避孕措施。

Most common Adverse Reactions:

最常见的不良反应：

For more information, see Full Prescribing Information.

有关更多信息，请参阅完整处方信息。

About Celltrion, Inc.

关于Celltrion公司

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.

Celltrion是一家领先的生物制药公司，专注于研究、开发、制造、营销和销售创新疗法，改善全球人民的生活。Celltrion是生物类似药领域的先驱，推出了全球首个单克隆抗体生物类似药。

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.

我们的全球制药产品组合涵盖多个治疗领域，包括免疫学、肿瘤学、血液学、眼科学和内分泌学。除了生物仿制药产品外，我们还致力于通过新型药物推进研发管线，突破科学创新的界限，提供高质量的药物。

For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook..

有关更多信息，请访问我们的网站 www.celltrion.com/en-us，并通过我们的社交媒体 LinkedIn、Instagram、X 和 Facebook 了解我们最新的新闻和活动。

About Celltrion USA

关于Celltrion美国

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 是 Celltrion 于2018年成立的美国子公司，总部位于新泽西州。Celltrion USA 致力于扩大创新生物制剂的获取渠道，以改善美国患者的医疗护理。Celltrion 获得 FDA 批准的生物类似药产品涵盖免疫学、肿瘤学、血液学和内分泌学领域，包括：INFLECTRA®（英夫利昔单抗-dyyb）、TRUXIMA®（利妥昔单抗-abbs）、HERZUMA®（曲妥珠单抗-pkrb）、VEGZELMA®（贝伐珠单抗-adcd）、YUFLYMA®（阿达木单抗-aaty）、AVTOZMA®（托珠单抗-anho）、STEQEYMA®（乌司奴单抗-stba）、STOBOCLO®（地诺单抗-bmwo）、OSENVELT®（地诺单抗-bmwo）和 OMLYCLO®（奥马珠单抗-igec），以及新型生物制剂 ZYMFENTRA®（英夫利昔单抗-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 www.celltrionusa.com and stay updated with our latest news and events on our social media - LinkedIn..

Celltrion美国公司将继续利用Celltrion在生物技术领域的独特传承、卓越的供应链以及一流的销售能力，为美国患者提供更好的高质量生物制药产品。欲了解更多信息，请访问www.celltrionusa.com，并通过我们的社交媒体LinkedIn关注最新动态和活动。

Forward-looking Statement

前瞻性声明

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.

本新闻稿中包含的某些信息涉及我们未来业务和财务表现以及与Celltrion, Inc.及其子公司相关的未来事件或发展的陈述，根据相关证券法，这些陈述可能构成前瞻性陈述。

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..

这些声明也可能通过诸如“准备”、“希望”、“即将到来”、“计划”、“旨在”、“即将推出”、“正在准备”、“一旦获得”、“可能”、“目的是”、“或许”、“一旦确定”、“将”、“努力实现”、“预定”、“可用”、“有潜力”、这些词语的否定形式或其他类似变化或相当术语来识别。

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.

此外，我们的代表可能会做出口头前瞻性陈述。这些陈述基于 Celltrion, Inc. 及其子公司管理层的当前预期和某些假设，其中许多超出了其控制范围。

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..

前瞻性声明旨在让潜在投资者有机会了解管理层对未来的信念和看法，以便他们可以将这些信念和看法作为评估投资的一个因素。这些声明并非未来业绩的保证，不应过度依赖它们。

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..

此类前瞻性陈述必然涉及与公司业务相关的已知和未知风险及不确定性，包括其年度报告和/或季度报告中披露的风险因素，这些因素可能导致未来期间的实际业绩和财务结果与任何前瞻性陈述所表达或暗示的未来业绩或结果存在重大差异。

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.

Celltrion公司及其子公司在情况发生变化或管理层的估计或意见有所调整时，不承担更新前瞻性声明的义务，除非适用的证券法要求。

Trademarks

商标

STOBOCLO® and OSENVELT® are registered trademarks of Celltrion, Inc.

STOBOCLO® 和 OSENVELT® 是 Celltrion, Inc. 的注册商标。

PROLIA® and XGEVA® are registered trademarks of Amgen Inc.

PROLIA® 和 XGEVA® 是安进公司的注册商标。

References

参考文献

For further information please contact:

如需更多信息，请联系：

Andria Arena

安德里亚竞技场

aarena@jpa.com

aarena@jpa.com

+1 516-578-0057

+1 516-578-0057

Source: prnewswire.com

来源：prnewswire.com