Accord BioPharma宣布地舒单抗生物类似药 OSVYRTI®（denosumab-desu）和 JUBEREQ®（denosumab-desu）已上市销售-动脉网

Accord BioPharma Announces Commercial Availability of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)

CISION 等信源发布 2026-07-23 20:05

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可切换为仅中文

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Biosimilars strengthen access to treatment for certain bone health conditions.

生物类似药增强了对某些骨骼健康疾病的治疗可及性。

RALEIGH, N.C.

北卡罗来纳州罗利

，

July 23, 2026

2026年7月23日

/PRNewswire/ --

/美通社/ --

Accord BioPharma

Accord 生物制药

, Inc., the U.S. specialty division of

，Inc.，其在美的专业部门

Intas Pharmaceuticals

英塔斯制药公司

, Ltd., focused on the development of oncology, immunology and central nervous system (CNS) therapies, today announced the launch of two denosumab biosimilars—OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)—expanding access to more affordable therapies for patients. OSVYRTI and JUBEREQ are FDA-approved as interchangeable biosimilars to Prolia® and XGEVA®, respectively, and represent Accord BioPharma's first products developed and manufactured end to end, by its parent entity..

有限公司（专注于肿瘤学、免疫学和中枢神经系统[CNS]疗法的开发）今日宣布推出两款地舒单抗生物类似药——OSVYRTI®（地舒单抗-desu）和JUBEREQ®（地舒单抗-desu），从而扩大患者对更具可负担性疗法的使用渠道。OSVYRTI和JUBEREQ分别获得美国食品药品监督管理局（FDA）批准，作为与Prolia®和XGEVA®可互换的生物类似药，也是其母公司从头到尾自主开发和制造的首批产品。

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OSVYRTI is 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, treatment of 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.

OSVYRTI 适用于治疗有高骨折风险的绝经后骨质疏松症女性，增加有高骨折风险的男性骨质疏松症患者的骨量，治疗有高骨折风险的男性和女性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且有高骨折风险的男性的骨量，以及增加接受乳腺癌辅助芳香化酶抑制剂疗法且有高骨折风险的女性的骨量。

As an interchangeable biosimilar to Prolia, OSVYRTI carries a Boxed Warning for severe hypocalcemia in patients with advanced kidney disease and was approved with a Risk Evaluation and Mitigation Strategy (REMS) program through which Accord will fulfill obligations related to such warning..

作为Prolia的可互换生物类似药，OSVYRTI带有针对晚期肾病患者严重低钙血症的黑框警告，并已通过风险评估与缓解策略（REMS）计划获得批准，Accord公司将通过该计划履行与此类警告相关的义务。

JUBEREQ is indicated for the 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, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy..

JUBEREQ 适用于预防多发性骨髓瘤患者以及实体瘤骨转移患者的骨骼相关事件；治疗不可切除或手术切除可能导致严重发病率的骨巨细胞瘤成人患者及骨骼成熟青少年患者；以及治疗对双膦酸盐疗法难治的恶性肿瘤高钙血症。

Please see below for Important Safety Information for OSVYRTI and JUBEREQ.

请参阅下方关于OSVYRTI和JUBEREQ的重要安全信息。

Strengthening Access to Treatment for Certain Bone Health Conditions

加强特定骨骼健康状况的治疗可及性

'For patients living with osteoporosis or cancer-related bone loss, the ability to access proven therapy is vital,' said Chrys Kokino, President, Accord North America. 'With the simultaneous launch of OSVYRTI and JUBEREQ, we are proud to provide access to additional options for these critical conditions and to back that commitment with real support for patients through AccordCares, our patient support program.'.

“对于患有骨质疏松症或癌症相关骨丢失的患者而言，获得经验证的治疗方案至关重要，”Accord北美公司总裁Chrys Kokino表示。“随着OSVYRTI和JUBEREQ的同步上市，我们自豪地为这些关键疾病提供更多的治疗选择，并通过我们的患者支持项目AccordCares，以切实的患者支持来践行这一承诺。”

Bone health conditions, including those for which OSVYRTI and JUBEREQ are approved, represent a significant and growing burden on patients and the U.S. healthcare system. Fragility fractures affect approximately 1.9 million Americans annually and are responsible for approximately 500,000 hospital admissions and 180,000 nursing home admissions.

骨骼健康状况，包括OSVYRTI和JUBEREQ获批适应症的疾病，给患者和美国医疗保健系统带来了沉重且日益增长的负担。脆性骨折每年影响约190万美国人，导致约50万次住院和18万次养老院入住。

The annual number of fractures is projected to increase to 3.2 million by 2040..

预计到2040年，每年骨折病例数将增至320万例。

An estimated 300,000 to 600,000 Americans are living with cancer-related bone metastases from solid tumors at any given time, and more than 35,000 Americans are diagnosed with multiple myeloma each year — a disease commonly associated with bone complications.

据估计，在任何给定时间，有30万至60万美国人患有来自实体瘤的癌症相关骨转移，每年有超过3.5万美国人被诊断患有多发性骨髓瘤——这是一种常与骨骼并发症相关的疾病。

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In 2024, Medicare Part B spending on denosumab products exceeded $2 billion, underscoring the need for more affordable alternatives.

2024年，联邦医疗保险B部分在地舒单抗产品上的支出超过20亿美元，凸显出对更具可负担性的替代方案的迫切需求。

OSVYRTI is available at a wholesaler acquisition cost (WAC) of $1,800.41 per 60 mg/mL single-dose pre-filled syringe, and JUBEREQ at a WAC price of $3,311.75 per 120 mg/1.7 mL (70 mg/mL) single-dose vial, supplying providers with more cost-efficient acquisition options for denosumab therapy.

OSVYRTI 的批发商采购成本（WAC）为每支 60 mg/mL 单剂量预充式注射器 1,800.41 美元，JUBEREQ 的 WAC 价格为每瓶 120 mg/1.7 mL（70 mg/mL）单剂量小瓶 3,311.75 美元，从而为医疗服务提供者提供更具成本效益的地诺单抗治疗采购选择。

Beyond pricing, Accord BioPharma has worked to ensure broad coverage of these products at launch. As of July 1

除了定价之外，Accord BioPharma 还致力于确保这些产品在上市时获得广泛的覆盖。截至7月1日

第一

, both brands are Preferred on Cigna Advantage, Performance, and Legacy Performance commercial pharmacy benefit drug lists. Additionally, on September 1

，这两个品牌均被列入信诺（Cigna）Advantage、Performance 和 Legacy Performance 商业药房福利药品清单的优选目录。此外，在9月1日

第一

, both brands will be Preferred on the Cigna commercial medical benefit. Through AccordCares, eligible commercially insured patients may be able to access both OSVYRTI and JUBEREQ for as little as $0.

这两个品牌都将成为Cigna商业医疗保险的首选。通过AccordCares，符合条件的商业保险患者可能能够以低至0美元的价格获得OSVYRTI和JUBEREQ。

A Milestone in Accord BioPharma's Growth

Accord BioPharma 发展史上的里程碑

Launching OSVYRTI and JUBEREQ marks another step in Accord BioPharma's evolution as a fully integrated biosimilar company: one that drives the science, the process, and the outcome. The company's goal of bringing 20 biosimilars to the U.S. market by 2030 reflects not just its ambition but also its infrastructure to deliver on it..

推出OSVYRTI和JUBEREQ标志着Accord BioPharma在向完全整合的生物类似药公司演进的过程中又迈出了重要一步：这是一家能够主导科学研发、生产工艺及最终成果的企业。该公司计划到2030年将20种生物类似药推向美国市场，这一目标不仅彰显了其雄心壮志，也体现了其实现该目标所具备的基础设施与执行能力。

'OSVYRTI and JUBEREQ represent a proud milestone in our work with Accord BioPharma to independently manufacture and bring these biosimilars to the U.S. market,' said Binish Chudgar, Chairman and Managing Director of Intas. 'Biosimilars have a critical and lasting role to play in the U.S. healthcare system, and we remain committed to helping more patients access the proven therapies they need, while delivering meaningful cost savings.'.

“OSVYRTI和JUBEREQ的推出，标志着我们在与Accord BioPharma合作、独立生产并将这些生物类似药引入美国市场方面取得了令人自豪的里程碑式进展。”Intas董事长兼总经理Binish Chudgar表示。“生物类似药在美国医疗体系中发挥着关键而持久的作用，我们依然致力于帮助更多患者获得他们所需的、经证实有效的治疗药物，同时实现显著的成本节约。”

Contact:

联系方式：

[email protected]

IMPORTANT SAFETY INFORMATION FOR

重要安全信息

OSVYRTI®

(denosumab-desu) injection, for subcutaneous use

（地舒单抗）注射液，供皮下注射使用

OSVYRTI

注册商标符号

(denosumab-desu) is biosimilar to PROLIA

（地舒单抗-desu）是PROLIA的生物类似药

注册商标符号

(denosumab)

(地舒单抗)

BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION

黑框警告及额外重要安全信息

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE

警告：晚期肾病患者出现严重低钙血症

See full prescribing information for complete boxed warning.

详见完整处方信息以获取完整的黑框警告。

• Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.

• 晚期慢性肾病患者在给予地诺单抗类药物后，发生严重低钙血症的风险更高。已有报道指出，严重低钙血症可导致住院、危及生命的事件以及死亡病例。

• The presence of chronic kidney disease-mineral bone disorder (CKD¬-MBD) markedly increases the risk of hypocalcemia.

• 慢性肾脏病-矿物质和骨异常（CKD-MBD）的存在显著增加低钙血症的风险。

• Prior to initiating OSVYRTI in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with OSVYRTI in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.

• 在晚期慢性肾病患者中开始使用 OSVYRTI 之前，应评估是否存在慢性肾脏病-矿物质和骨异常（CKD-MBD）。对这些患者使用 OSVYRTI 进行治疗时，应由在诊断和管理 CKD-MBD 方面具有专业知识的医疗保健提供者进行监督。

Contraindications:

禁忌症：

OSVYRTI is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating OSVYRTI. OSVYRTI is contraindicated in women who are pregnant and may cause fetal harm. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment. OSVYRTI is contraindicated in patients with hypersensitivity to denosumab products.

OSVYRTI 禁用于低钙血症患者。在开始使用 OSVYRTI 之前，必须纠正既存的低钙血症。OSVYRTI 禁用于孕妇，并可能对胎儿造成伤害。对于具有生育潜力的女性，应在开始治疗前进行妊娠测试。OSVYRTI 禁用于对地舒单抗类产品过敏的患者。

Reactions have included anaphylaxis, facial swelling and urticaria..

不良反应包括过敏性休克、面部肿胀和荨麻疹。

Severe Hypocalcemia and Mineral Metabolism Changes:

严重低钙血症及矿物质代谢改变：

Pre-existing hypocalcemia must be corrected prior to initiating therapy; severe hypocalcemia and fatal cases have been reported with denosumab products. Adequately supplement all patients with calcium and vitamin D.

在开始治疗前，必须纠正已存在的低钙血症；已有使用地舒单抗产品导致严重低钙血症及致死病例的报告。应为所有患者充分补充钙剂和维生素D。

In patients without advanced CKD who are predisposed to hypocalcemia and disturbances of mineral metabolism, assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after OSVYRTI injection. In some postmarketing cases, hypocalcemia persisted for weeks or months and required frequent monitoring and intravenous and/or oral calcium replacement, with or without vitamin D..

对于无晚期慢性肾脏病（CKD）但易发生低钙血症和矿物质代谢紊乱的患者，应在注射 OSVYRTI 后 10 至 14 天评估血清钙及矿物质（磷和镁）水平。在某些上市后病例中，低钙血症持续数周或数月，需要频繁监测并进行静脉和/或口服钙补充治疗，伴或不伴维生素 D 治疗。

Patients with Advanced Chronic Kidney Disease

晚期慢性肾病患者

Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m²), including dialysis-dependent patients, are at high risk for severe hypocalcemia after denosumab products administration, which can lead to hospitalization, life-threatening events, or death. CKD-MBD and concomitant calcimimetic use further increase risk..

晚期慢性肾脏病（eGFR <30 mL/min/1.73 m²）患者，包括依赖透析的患者，在给予地舒单抗产品后发生严重低钙血症的风险较高，可能导致住院、危及生命的事件或死亡。慢性肾脏病-矿物质和骨异常（CKD-MBD）以及同时使用拟钙剂会进一步增加风险。

Assess for mineral bone disorder before OSVYRTI treatment, monitor serum calcium weekly for the first month, then monthly, and educate patients on hypocalcemia symptoms and the need for adequate calcium and activated vitamin D supplementation.

在开始OSVYRTI治疗前评估矿物质骨代谢紊乱情况，治疗首月每周监测血清钙水平，之后每月监测一次，并对患者进行低钙血症症状教育，强调充分补充钙剂和活性维生素D的必要性。

Same Active Ingredient:

相同活性成分：

Patients receiving OSVYRTI should not receive other denosumab products concomitantly.

接受 OSVYRTI 治疗的患者不应同时使用其他地舒单抗产品。

Hypersensitivity:

超敏反应：

Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. Symptoms included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSVYRTI..

已有报告指出，使用地舒单抗类产品可能出现具有临床意义的超敏反应，包括过敏性休克。症状包括低血压、呼吸困难、喉咙发紧、面部及上呼吸道水肿、瘙痒和荨麻疹。如果发生过敏性休克或其他具有临床意义的过敏反应，应立即启动适当的治疗，并停止继续使用OSVYRTI。

Osteonecrosis of the Jaw (ONJ):

颌骨坏死（ONJ）：

ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has been reported in patients receiving denosumab products. An oral exam should be performed prior to initiation of OSVYRTI. Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ.

下颌骨坏死（ONJ）可自发发生，通常与拔牙和/或局部感染导致的愈合延迟相关，并在接受地舒单抗类药物治疗的患者中已有报告。在开始使用OSVYRTI之前，应进行口腔检查。同时使用与ONJ相关的药物可能会增加发生ONJ的风险。

The risk of ONJ may increase with duration of exposure to denosumab products..

颌骨坏死（ONJ）的风险可能随着使用地舒单抗类产品时间的延长而增加。

For patients requiring invasive dental procedures, clinical judgment should guide the management plan based on individual benefit-risk assessment.

对于需要接受侵入性牙科手术的患者，应根据个体化的获益-风险评估，由临床判断指导管理方案。

Patients suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of OSVYRTI should be considered based on individual benefit-risk assessment.

疑似患有或发生下颌骨坏死（ONJ）的患者应由牙医或口腔外科医生进行诊治。为治疗 ONJ 而进行的大范围牙科手术可能会加重病情。应根据个体获益-风险评估考虑停用 OSVYRTI。

Atypical

非典型

Subtrochanteric

转子下

and

和

Diaphyseal

骨干的

Femoral

股骨的

Fractures

骨折

：

Atypical low-energy, or low trauma fractures of the shaft have been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

已有报道指出，使用地舒单抗产品可能出现非典型低能量或低创伤性骨干骨折。这些骨折可发生于股骨干的任何部位，范围从小转子下方至髁上隆起上方，骨折线呈横向或短斜向，无粉碎性骨折迹象。

Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents..

由于这些骨折也发生在未接受抗骨吸收药物治疗的骨质疏松患者中，因此尚未确立因果关系。

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral, and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g.

非典型股骨骨折最常发生在受影响区域受到轻微或无创伤的情况下。它们可能是双侧的，许多患者报告在完全骨折发生前数周至数月，受影响区域出现前驱疼痛，通常表现为大腿部的钝痛、酸痛。一些报告指出，患者还同时接受糖皮质激素治疗（例如

prednisone) at the time of fracture. .

骨折时服用泼尼松）。

During OSVYRTI treatment, advise patients to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb.

在接受OSVYRTI治疗期间，建议患者报告新出现或异常的 thigh（大腿）、hip（髋部）或 groin（腹股沟）疼痛。任何出现大腿或腹股沟疼痛的患者都应接受评估，以排除不完全性股骨骨折。对于出现非典型股骨骨折的患者，还应评估其对侧肢体是否存在骨折的症状和体征。

Interruption of OSVYRTI therapy should be considered, pending a risk/benefit assessment, on an individual basis..

应基于个体情况，在进行风险/获益评估后，考虑中断OSVYRTI治疗。

Multiple Vertebral Fractures Following Discontinuation of Treatment:

停药后发生的多发性椎体骨折：

Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures.

停用狄诺塞麦治疗后，骨折风险增加，包括多发性椎体骨折的风险。

New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab discontinuation. Evaluate an individual's benefit/risk before initiating treatment with OSVYRTI. If OSVYRTI treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy..

新的椎体骨折最早可在地舒单抗末次给药后7个月发生（平均19个月）。既往椎体骨折是地舒单抗停药后发生多发性椎体骨折的预测因素。在开始OSVYRTI治疗前，应评估个体的获益/风险。如果停用OSVYRTI治疗，患者应转换为另一种抗骨吸收疗法。

Serious Infections:

严重感染：

Serious infections leading to hospitalization were reported more frequently in patients taking denosumab. Serious skin infections, and infections of the abdomen, urinary tract and ear were more frequent in patients treated with denosumab.

接受地舒单抗治疗的患者中，导致住院的严重感染报告更为频繁。在地舒单抗治疗的患者中，严重皮肤感染以及腹部、泌尿道和耳部感染的发生率更高。

Endocarditis was also reported more frequently in denosumab-treated patients. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.

在接受地舒单抗治疗的患者中，心内膜炎的报告也更为频繁。建议患者若出现包括蜂窝织炎在内的严重感染体征或症状，应立即就医。

Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on OSVYRTI, prescribers should assess the need for continued therapy.

同时使用免疫抑制剂或免疫系统受损的患者发生严重感染的风险可能增加。对于在使用 OSVYRTI 期间发生严重感染的患者，处方者应评估继续治疗的必要性。

Dermatologic Adverse Reactions:

皮肤不良反应：

Epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate in patients taking denosumab. Most of these events were not specific to the injection site. Consider discontinuing OSVYRTI if severe symptoms develop.

在使用地舒单抗的患者中，皮炎、湿疹和皮疹等表皮和真皮不良事件的发生率显著更高。这些事件大多并非特异性发生于注射部位。如果出现严重症状，应考虑停用OSVYRTI。

Musculoskeletal Pain:

肌肉骨骼疼痛：

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported with denosumab products. Consider discontinuing OSVYRTI use if severe symptoms develop.

已有报告指出，使用地舒单抗类产品可能导致严重且偶尔致残的骨骼、关节和/或肌肉疼痛。如果出现严重症状，应考虑停用OSVYRTI。

Suppression of Bone Turnover:

抑制骨转换：

Treatment with denosumab resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance and effect of long-term treatment with denosumab products are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing..

地舒单抗治疗显著抑制了骨重塑，骨转换标志物和骨组织形态计量学结果均证实了这一点。长期接受地舒单抗类药物治疗的意义和影响尚不明确。应监测患者是否出现包括下颌骨坏死、非典型骨折以及骨折愈合延迟在内的不良后果。

Hypercalcemia

高钙血症

在

Pediatric

儿科

Patients

患者

with

和

Osteogenesis

骨生成

Imperfecta:

不完美者：

OSVYRTI is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products. Some cases required hospitalization.

OSVYRTI 未获批用于儿科患者。已有报告称，在接受地舒单抗类产品治疗的成骨不全症儿科患者中出现高钙血症。部分病例需要住院治疗。

Most Common Adverse Reactions:

最常见的不良反应：

Postmenopausal

绝经后

osteoporosis:

骨质疏松症：

Greater than 5% and more common than placebo: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.

发生率高于5%且高于安慰剂组的不良反应包括：背痛、四肢疼痛、高胆固醇血症、肌肉骨骼疼痛和膀胱炎。临床试验中已有胰腺炎的报道。

Male osteoporosis:

男性骨质疏松症：

Greater than 5% and more common than placebo: back pain, arthralgia, and nasopharyngitis.

发生率大于5%且高于安慰剂组的不良反应：背痛、关节痛和鼻咽炎。

Glucocorticoid-induced

糖皮质激素诱导的

osteoporosis:

骨质疏松症：

Greater than 3% and more common than active-control group were: back pain, hypertension, bronchitis, and headache.

发生率高于3%且高于活性对照组的不良事件包括：背痛、高血压、支气管炎和头痛。

Bone loss due to hormone ablation for cancer:

癌症激素消融治疗导致的骨质流失：

Greater than or equal to 10% and more common than placebo: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.

发生率≥10%且高于安慰剂：关节痛和背痛。临床试验中也报告了四肢疼痛和肌肉骨骼疼痛。

INDICATIONS

适应症

OSVYRTI is a RANK ligand (RANKL) inhibitor indicated for treatment:

OSVYRTI 是一种 RANK 配体（RANKL）抑制剂，适用于治疗：

of postmenopausal women with osteoporosis at high risk for fracture

患有骨质疏松症且骨折高风险的绝经后妇女

to increase bone mass in men with osteoporosis at high risk for fracture

增加骨折高风险的骨质疏松男性患者的骨量

of glucocorticoid-induced osteoporosis in men and women at high risk for fracture

糖皮质激素诱导的骨质疏松症在骨折高风险的男性和女性中的情况

to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer

用于增加接受雄激素剥夺疗法治疗非转移性前列腺癌的高骨折风险男性的骨量

to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

用于增加接受辅助芳香化酶抑制剂治疗乳腺癌的高骨折风险女性的骨量

To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or

如需报告疑似不良反应，请致电 1-866-941-7875 联系 Accord BioPharma Inc，或致电 1-800-FDA-1088 联系美国食品药品监督管理局（FDA），或

www.fda.gov/medwatch

。

OSVYRTI (denosumab-desu) injection is supplied in a 60 mg/mL single-dose prefilled syringe.

OSVYRTI（地舒单抗）注射液以60 mg/mL单剂量预充式注射器的形式提供。

Click here for

点击此处

full Prescribing Information

完整处方信息

，

including Boxed Warning

包括黑框警告

。

PROLIA

普罗力

(denosumab) is a registered trademark of Amgen Inc.

（地舒单抗）是安进公司的注册商标。

IMPORTANT SAFETY INFORMATION FOR

重要安全信息

JUBEREQ®

(denosumab-desu) injection, for subcutaneous use

地舒单抗注射液，用于皮下注射

JUBEREQ

请求执行

(denosumab-desu) is biosimilar to XGEVA

（地舒单抗）是XGEVA的生物类似药

(denosumab)

（地舒单抗）

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications:

禁忌症：

JUBEREQ is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy. JUBEREQ is contraindicated in patients with known clinically significant hypersensitivity to denosumab products.

JUBEREQ 禁用于低钙血症患者。在开始治疗前，必须纠正既存的低钙血症。JUBEREQ 禁用于已知对地舒单抗产品存在临床显著过敏反应的患者。

Same Active Ingredient:

相同活性成分：

Patients receiving JUBEREQ should not receive other denosumab products concomitantly.

接受JUBEREQ治疗的患者不应同时使用其他地舒单抗产品。

Hypersensitivity:

超敏反应：

Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue JUBEREQ therapy permanently..

已有报告指出，使用地舒单抗产品可能出现具有临床意义的超敏反应，包括过敏性休克。这些反应可能包括低血压、呼吸困难、上呼吸道水肿、唇部肿胀、皮疹、瘙痒和荨麻疹。如果发生过敏性休克或其他具有临床意义的过敏反应，应立即开始适当的治疗，并永久停用JUBEREQ。

Hypocalcemia:

低钙血症：

Severe symptomatic hypocalcemia and fatal cases have been reported. Correct pre-existing hypocalcemia prior to JUBEREQ treatment, and fatal cases have been reported. Monitor calcium levels throughout therapy, especially in the first weeks, and administer calcium, magnesium, and vitamin D as necessary.

已有严重症状性低钙血症及致死病例的报告。在开始JUBEREQ治疗前，应纠正已存在的低钙血症。在整个治疗期间，尤其是在最初几周内，应监测血钙水平，并根据需要补充钙、镁和维生素D。

Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare provider for symptoms of hypocalcemia..

拟钙剂与其他可能降低钙水平的药物合用可能会增加低钙血症的风险，因此应密切监测血清钙水平。建议患者出现低钙血症症状时联系医疗保健提供者。

Increased risk of hypocalcemia has been observed in patients with renal dysfunction, most commonly with severe dysfunction CrCl (<30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

在肾功能不全患者中，已观察到低钙血症风险增加，最常见于严重肾功能不全（肌酐清除率 <30 mL/min 和/或接受透析）以及钙补充不足或未补充钙的患者。应监测血钙水平以及钙和维生素D的摄入量。

Osteonecrosis of the Jaw (ONJ):

颌骨坏死（ONJ）：

ONJ has been reported manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials the incidence of ONJ was higher with longer duration of exposure..

据报道，颌骨坏死（ONJ）可表现为颌骨疼痛、骨髓炎、骨炎、骨质侵蚀、牙齿或牙周感染、牙痛、牙龈溃疡或牙龈侵蚀。牙科手术后口腔或颌骨持续疼痛或愈合缓慢也可能是ONJ的表现。在临床试验中，随着暴露时间的延长，ONJ的发生率更高。

Predisposing factors for developing ONJ include a history of tooth extraction, poor oral hygiene, and use of a dental appliance. Other risk factors include immunosuppressive therapy, use of angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

发生颌骨坏死（ONJ）的易感因素包括拔牙史、口腔卫生不良以及使用牙科器具。其他风险因素包括免疫抑制治疗、使用血管生成抑制剂、全身性皮质类固醇、糖尿病和牙龈感染。

Perform an oral examination and appropriate preventive dentistry prior to the initiation of JUBEREQ and periodically during therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment. Consider temporary discontinuation of JUBEREQ if an invasive dental procedure must be performed..

在开始使用 JUBEREQ 之前以及治疗期间定期进行口腔检查和适当的预防性牙科护理。指导患者注意口腔卫生实践。在治疗期间避免进行侵入性牙科操作。如果必须进行侵入性牙科操作，应考虑暂时停用 JUBEREQ。

Patients who are suspected of having or who develop ONJ while on JUBEREQ should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

对于在使用JUBEREQ期间疑似患有或发展为ONJ（颌骨坏死）的患者，应由牙医或口腔外科医生进行护理。在这些患者中，为治疗ONJ而进行的广泛牙科手术可能会加重病情。

Atypical

非典型

Subtrochanteric

转子下

and

和

Diaphyseal

骨干

Femoral

股骨的

Fractures

骨折

：

Atypical femoral fractures have been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

已有使用地舒单抗产品导致非典型股骨骨折的报道。这些骨折可发生于股骨干的任何部位，范围从小转子下方至髁上隆起上方，骨折线呈横向或短斜向，无粉碎性骨折证据。

During JUBEREQ treatment, advise patients to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb.

在JUBEREQ治疗期间，应建议患者报告新出现或异常的大腿、髋部或腹股沟疼痛。任何出现大腿或腹股沟疼痛的患者都应接受评估，以排除不完全性股骨骨折。对于出现非典型股骨骨折的患者，还应评估其对侧肢体是否存在骨折的症状和体征。

Interruption of JUBEREQ therapy should be considered, pending a risk/benefit assessment. .

应考虑中断 JUBEREQ 治疗，待进行风险/获益评估后决定。

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons:

骨巨细胞瘤患者及骨骼生长患者停药后的高钙血症：

Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in denosumab product-treated patients with giant cell tumor of bone and patients with growing skeletons within one year of treatment discontinuation. Monitor for signs and symptoms of hypercalcemia after treatment discontinuation and treat appropriately..

已有报告称，在接受地舒单抗治疗的骨巨细胞瘤患者以及骨骼仍在生长的患者中，在停药后一年内出现了具有临床意义的高钙血症，需住院治疗并并发急性肾损伤。应在停药后监测高钙血症的体征和症状，并给予适当治疗。

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation:

停药后多发性椎体骨折（MVF）：

MVF have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When JUBEREQ treatment is discontinued, evaluate the patient's risk for vertebral fractures

已有报告指出，在停用地诺单抗类产品治疗后出现多发性椎体骨折（MVF）。MVF高风险患者包括具有骨质疏松症或既往骨折风险因素或病史的患者。当停用JUBEREQ治疗时，应评估患者的椎体骨折风险。

。

Embryo-Fetal Toxicity:

胚胎-胎儿毒性：

JUBEREQ can cause fetal harm when administered to a pregnant woman. Based on data from animal studies and its mechanism of action, JUBEREQ is expected to result in adverse reproductive effects.

JUBEREQ 在用于孕妇时可能导致胎儿损害。根据动物研究数据及其作用机制，预计 JUBEREQ 会产生不良生殖影响。

Verify the pregnancy status of females of reproductive potential prior to the initiation of JUBEREQ. Advise pregnant women and females of reproductive potential that exposure to JUBEREQ during pregnancy or within 5 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of JUBEREQ.

在开始使用JUBEREQ之前，需验证具有生育能力女性的妊娠状态。应告知孕妇及具有生育能力的女性，在妊娠期间或受孕前5个月内暴露于JUBEREQ可能导致胎儿损害。建议具有生育能力的女性在治疗期间以及末次服用JUBEREQ后至少5个月内采取有效的避孕措施。

。

Most Common Adverse Reactions:

最常见不良反应：

Bone Metastasis from Solid Tumors:

实体瘤骨转移：

Greater than or equal to 25%: fatigue/asthenia, hypophosphatemia, and nausea.

发生率≥25%：疲劳/乏力、低磷血症和恶心。

Multiple Myeloma:

多发性骨髓瘤：

Greater than or equal to 10%: diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.

发生率大于或等于10%：腹泻、恶心、贫血、背痛、血小板减少症、外周水肿、低钙血症、上呼吸道感染、皮疹和头痛。

Giant Cell Tumor of Bone:

骨巨细胞瘤：

Greater than or equal to 10%: arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.

大于或等于10%：关节痛、头痛、恶心、背痛、疲劳和肢体疼痛。

Hypercalcemia of Malignancy:

恶性肿瘤相关高钙血症：

Greater than 20%: nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

发生率大于20%：恶心、呼吸困难、食欲减退、头痛、外周水肿、呕吐、贫血、便秘和腹泻。

INDICATIONS

适应症

JUBEREQ is a RANK ligand (RANKL) inhibitor indicated for:

JUBEREQ 是一种 RANK 配体（RANKL）抑制剂，适用于：

Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

预防多发性骨髓瘤患者以及实体瘤骨转移患者的骨骼相关事件。

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.

用于治疗成人及骨骼发育成熟的青少年患者，其患有无法手术切除或手术切除可能导致严重残疾的骨巨细胞瘤。

Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

双膦酸盐治疗无效的恶性肿瘤相关高钙血症的治疗。

到

report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or

报告疑似不良反应，请致电 1-866-941-7875 联系 Accord BioPharma Inc，或

FDA

美国食品药品监督管理局

在

1-800-FDA-1088

或

www.fda.gov/medwatch

。

JUBEREQ (denosumab-desu) injection is supplied in a 120 mg/1.7 mL (70 mg/mL) single-dose vial.

JUBEREQ（地舒单抗）注射液以120 mg/1.7 mL（70 mg/mL）的单剂量小瓶形式提供。

Click here for

点击这里获取

full Prescribing Information

完整处方信息

。

XGEVA

(denosumab) is a registered trademark of Amgen Inc.

（地舒单抗）是安进公司的注册商标。

About Accord BioPharma

关于 Accord BioPharma

Accord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies.

Accord BioPharma, Inc. 是 Intas Pharmaceuticals, Ltd. 的美国专业部门，而 Intas 是全球经验最丰富的生物类似药开发商之一。Accord BioPharma 专注于肿瘤学、免疫学和中枢神经系统（CNS）治疗领域，致力于扩大患者对高质量、可负担的生物制剂疗法的可及性。

The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab); JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab); ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA®; and CAMCEVI® (leuprolide mesylate) injectable emulsion.

该公司获美国食品药品监督管理局（FDA）批准的商业产品组合包括：UDENYCA®（pegfilgrastim-cbqv）——NEULASTA®（聚乙二醇化非格司亭）的生物类似药；FILKRI™（filgrastim-laha）——NEUPOGEN®（非格司亭）的生物类似药；IMULDOSA®（ustekinumab-srlf）——STELARA®（乌司奴单抗）的生物类似药；HERCESSI™（trastuzumab-strf）——HERCEPTIN®（曲妥珠单抗）的生物类似药；OSVYRTI®（denosumab-desu）——Prolia®（地舒单抗）的生物类似药；JUBEREQ®（denosumab-desu）——Xgeva®（地舒单抗）的生物类似药；ENNUMO™（pegfilgrastim-pccg）——NEULASTA®的生物类似药；以及CAMCEVI®（亮丙瑞林甲磺酸盐）可注射乳剂。

Accord BioPharma has received FDA approval on additional products including IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab). The company's strategic goal is to launch 20 biosimilar products in the U.S.

Accord BioPharma 已获得美国食品药品监督管理局（FDA）对更多产品的批准，其中包括 IMMGOLIS™（golimumab-sldi）——Simponi®（戈利木单抗）的生物类似药，以及 IMMGOLIS INTRI™（golimumab-sldi）——Simponi Aria®（戈利木单抗）的生物类似药。该公司的战略目标是在美国推出20种生物类似药产品。

by 2030. For more information, visit .

到2030年。欲了解更多信息，请访问。

www.accordbiopharma.com

。

References:

参考文献：

OSVYRTI® (denosumab-desu) Prescribing Information. Accord BioPharma.

OSVYRTI®（地舒单抗）处方信息。Accord BioPharma。

JUBEREQ® (denosumab-desu) Prescribing Information. Accord BioPharma.

JUBEREQ®（地舒单抗）处方信息。Accord BioPharma。

Prolia® (denosumab) Prescribing Information. Amgen.

Prolia®（地舒单抗）处方信息。安进公司。