FILKRI is available with a permanent Q-code, standardizing the billing and reimbursement process across all sites of care.

FILKRI 配有永久性的 Q 代码，从而在所有医疗场所统一计费和报销流程。

RALEIGH, N.C.

北卡罗来纳州罗利

,

，

Oct. 12, 2026

2026年10月12日

/PRNewswire/ --

/美通社/ --

Accord BioPharma

Accord BioPharma

, Inc., the specialty division of

，Inc.，旗下的专业部门

Intas Pharmaceuticals, Ltd.

英塔斯制药有限公司

, focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today the U.S. commercial launch of FILKRI™(filgrastim-laha), a biosimilar to Neupogen® (filgrastim). FDA-approved in January 2026, FILKRI represents Accord BioPharma's continued expansion into oncology supportive care and furthers the company's goal to bring 20 biosimilars to the U.S.

，专注于肿瘤学、免疫学和中枢神经系统（CNS）疗法开发的公司，今天宣布在美国商业推出FILKRI™（filgrastim-laha），这是Neupogen®（filgrastim）的生物类似药。FILKRI于2026年1月获得FDA批准，代表了Accord BioPharma在肿瘤支持治疗领域的持续扩展，并进一步推进了该公司将20种生物类似药引入美国市场的目标。

market by 2030..

到2030年的市场。

1

1

FILKRI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).

FILKRI 适用于以下情况：降低接受与严重发热性中性粒细胞减少症显著发生率相关的骨髓抑制性抗癌药物的非髓系恶性肿瘤患者的感染发生率（表现为发热性中性粒细胞减少症）；缩短急性髓系白血病（AML）患者在诱导或巩固化疗后的中性粒细胞恢复时间及发热持续时间；缩短接受清髓性化疗随后进行骨髓移植的非髓系恶性肿瘤患者的中性粒细胞减少症持续时间及中性粒细胞减少症相关的临床后遗症（例如发热性中性粒细胞减少症）的持续时间；降低有症状的先天性中性粒细胞减少症、周期性中性粒细胞减少症或特发性中性粒细胞减少症患者的严重中性粒细胞减少症后遗症（例如发热、感染、口咽溃疡）的发生率和持续时间；以及提高急性暴露于骨髓抑制性辐射剂量（急性辐射综合征的造血综合征）患者的生存率。

FILKRI is available in 300 mcg/0.5 mL and 480 mcg/0.8 mL prefilled syringe presentations, with pack sizes of one or 10 prefilled syringes per carton..

FILKRI 有 300 mcg/0.5 mL 和 480 mcg/0.8 mL 两种预充式注射剂规格，每盒包装含 1 支或 10 支预充式注射器。

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The addition of FILKRI expands Accord BioPharma's granulocyte colony-stimulating factor (G-CSF) portfolio, giving U.S. physicians access to both short- and long-acting treatment options through FILKRI and UDENYCA

FILKRI 的加入扩大了 Accord BioPharma 的粒细胞集落刺激因子（G-CSF）产品组合，使美国医生能够通过 FILKRI 和 UDENYCA 获得短效和长效治疗选择。

®

®

(pegfilgrastim-cbqv). These options help meet the individual needs of patients undergoing chemotherapy and their healthcare providers.

（培非格司亭-cbqv）。这些选项有助于满足接受化疗的患者及其医疗保健提供者的个体化需求。

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2

FILKRI will be manufactured end to end by Accord BioPharma's parent entity, Intas, and has been assigned a permanent Q-code (Q5172) by the U.S. Centers for Medicare & Medicaid Services (CMS), effective October 1, which will standardize the billing and reimbursement process across all sites of care.

FILKRI 将由 Accord BioPharma 的母公司 Intas 进行端到端生产，并已被美国医疗保险和医疗补助服务中心（CMS）分配了一个永久 Q 代码（Q5172），该代码自 10 月 1 日起生效，这将使所有护理场所的 billing 和报销流程标准化。

'The commercial launch of FILKRI with a permanent Q-code from day one is a significant milestone for Accord BioPharma and for cancer patients across the United States,' said Chrys Kokino, President of Accord North America. 'Having a permanent Q-code will simplify billing and streamline reimbursement, making it more timely and reliable for physicians treating patients.'.

“FILKRI 从上市首日起即拥有永久 Q 代码，这对 Accord BioPharma 以及全美癌症患者而言是一个重要的里程碑。”Accord 北美公司总裁 Chrys Kokino 表示，“拥有永久 Q 代码将简化计费流程并优化报销程序，使为接受治疗的患者提供服务的医师能够更及时、更可靠地完成报销。”

Addressing Critical Patient Needs in Neutropenia Management

应对中性粒细胞减少症管理中的关键患者需求

As a G-CSF, FILKRI is indicated for use across several clinical settings in which neutropenia or its complications may occur, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Neutropenia is a condition characterized by lower-than-normal levels of neutrophils, a type of white blood cell that helps the body fight infections.

作为粒细胞集落刺激因子（G-CSF），FILKRI 适用于多种可能出现中性粒细胞减少症或其并发症的临床场景，并用于提高急性暴露于骨髓抑制性辐射剂量患者的生存率。中性粒细胞减少症是一种以中性粒细胞水平低于正常值为特征的疾病，中性粒细胞是帮助机体抵抗感染的一类白细胞。

Cancer treatments, including chemotherapy, can damage neutrophils or the bone marrow that produces them..

包括化疗在内的癌症治疗可能会损伤中性粒细胞或产生这些细胞的中枢骨髓。

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'With FILKRI, alongside our established UDENYCA pegfilgrastim franchise, Accord now offers physicians the choice between long-acting and short-acting biosimilar G-CSF treatments to suit their clinical needs and preferences,' Kokino added. 'This demonstrates our deep commitment to oncology supportive care and positions us as a comprehensive partner for the oncology community.'.

“凭借 FILKRI，以及我们已建立的 UDENYCA 聚乙二醇化非格司亭产品系列，Accord 现在为医生提供了长效和短效生物类似物 G-CSF 治疗之间的选择，以满足他们的临床需求和偏好，”科基诺补充道。“这彰显了我们对肿瘤支持治疗的坚定承诺，并使我们成为肿瘤学界的全面合作伙伴。”

Filgrastim biosimilars have become well established in the U.S. market, accounting for approximately 77% of filgrastim market share as of the fourth quarter of 2025.

非格司亭生物类似药在美国市场已稳固确立，截至2025年第四季度，约占非格司亭市场份额的77%。

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4

Expanding Access Through Competitive Pricing and Patient Support

通过竞争性定价和患者支持扩大可及性

Through AccordCares®, a dedicated patient support program, the company is launching FILKRI with comprehensive patient resources, including benefits investigation and co-pay assistance, designed to connect patients to the information and resources they need, building on the proven foundation established with UDENYCA..

通过AccordCares®这一专用的患者支持项目，公司推出FILKRI并提供全面的患者资源，包括福利核查和共付额援助，旨在帮助患者获取所需的信息和资源，此举建立在UDENYCA已验证的坚实基础之上。

'At Accord, we believe that cost shouldn't prevent patients from receiving the cancer care they need,' said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. 'With FILKRI, we're continuing to build on our track record of bringing high-quality biosimilars to market that provide physicians more choice and can make a real difference in patient care and patient affordability.

Accord BioPharma 数字与营销战略及运营高级副总裁 Nuvan Dassanaike 表示：“在 Accord，我们坚信费用不应成为患者获得所需癌症治疗的障碍。通过 FILKRI，我们继续秉承将高质量生物类似药推向市场的优良传统，为医生提供更多选择，并切实改善患者护理和提升患者的用药可负担性。”

The permanent Q-code further enhances our ability to expand patient access from launch.'.

永久性Q代码进一步增强了我们在产品上市之初扩大患者可及性的能力。

Building on Proven Leadership in Oncology Supportive Care

依托在肿瘤支持治疗领域经证实的领导力

'The launch of FILKRI in the United States demonstrates our unwavering commitment to building a comprehensive oncology supportive care portfolio that addresses urgent medical needs,' said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. 'With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape by introducing biosimilars to the U.S.

“FILKRI在美国的上市，彰显了我们坚定不移地致力于构建全面的肿瘤支持治疗产品组合，以满足迫切的医疗需求。”Intas Pharmaceuticals董事长兼总经理Binish Chudgar表示。“在拥有近五十年经验的全球领先企业Intas的支持下，Accord BioPharma正通过向美国市场引入生物类似药，改变传统的治疗格局。

market. As our presence in the biosimilar market continues to grow, so does our commitment to offering high-quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need.'.

市场。随着我们在生物类似药市场的存在感不断增强，我们致力于提供高质量、价格合理的原研药替代方案，从而使更多患者能够获得所需的治疗。

FDA approval of FILKRI was based on data demonstrating that FILKRI is highly similar to Neupogen, with no clinically meaningful differences.

FILKRI 获得美国食品药品监督管理局（FDA）批准是基于相关数据，这些数据表明 FILKRI 与 Neupogen 高度相似，且不存在具有临床意义的差异。

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IMPORTANT SAFETY INFORMATION

重要安全信息

FILKRI is contraindicated

FILKRI 禁忌使用

in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products.

适用于有对人粒细胞集落刺激因子（G-CSFs，如非格司亭或聚乙二醇化非格司亭产品）严重过敏史的患者。

Splenic Rupture:

脾破裂：

Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

已有在使用非格司亭制剂后发生脾破裂（包括致死病例）的报告。对于主诉左上腹或肩部疼痛的患者，应评估是否存在脾肿大或脾破裂。

Acute Respiratory Distress Syndrome (ARDS):

急性呼吸窘迫综合征（ARDS）：

ARDS has been reported in patients receiving filgrastim products

已有报告称，接受非格司亭制剂治疗的患者出现急性呼吸窘迫综合征（ARDS）。

.

。

Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS

对出现发热、肺部浸润或呼吸窘迫的患者进行急性呼吸窘迫综合征（ARDS）评估

.

。

Discontinue FILKRI in patients with ARDS.

在患有急性呼吸窘迫综合征（ARDS）的患者中停用 FILKRI。

Serious Allergic Reactions:

严重过敏反应：

Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products

已有报告指出，接受非格司亭制剂治疗的患者发生严重过敏反应，包括过敏性休克。

.

。

The majority of reported events occurred upon initial exposure

大多数报告的事件发生在初次暴露时

.

。

Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment

对过敏反应进行对症治疗。在接受非格司亭类产品治疗的患者中，包括过敏性休克在内的过敏反应可能在初始抗过敏治疗停药后数天内复发。

.

。

Permanently discontinue FILKRI in patients with serious allergic reactions.

对于出现严重过敏反应的患者，应永久停用 FILKRI。

Sickle Cell Disorders:

镰状细胞病：

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products

接受非格司亭产品的镰状细胞病患者可能发生严重且有时致命的镰状细胞危象

.

。

Discontinue FILKRI if sickle cell crisis occurs.

若发生镰状细胞危象，请停用 FILKRI。

Glomerulonephritis:

肾小球肾炎：

Has occurred in patients receiving filgrastim products

在接受非格司亭产品治疗的患者中已发生

.

。

Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy

诊断依据为氮质血症、血尿、蛋白尿及肾活检。

.

。

Generally, events resolved after dose reduction or discontinuation of filgrastim products

通常，在减少剂量或停用非格司亭类产品后，事件得以解决

.

。

If causality is likely, consider dose-reduction or interruption of FILKRI.

如果因果关系可能性较大，应考虑减少FILKRI剂量或中断给药。

Alveolar Hemorrhage and Hemoptysis:

肺泡出血与咯血：

Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, have been reported in FILKRI-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization

在接受FILKRI治疗以动员外周血祖细胞（PBPC）采集的健康供者中，已有肺泡出血的报告，其表现为肺部浸润和需要住院治疗的咯血。

.

。

Hemoptysis resolved with discontinuation of filgrastim products. The use of FILKRI for PBPC mobilization in healthy donors is not an approved indication.

停用非格司亭制剂后，咯血症状缓解。FILKRI用于健康供者外周血祖细胞动员的适应症尚未获批。

Capillary Leak Syndrome (CLS):

毛细血管渗漏综合征（CLS）：

CLS has been reported after G-CSF administration, including filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed

已有报道指出，在使用粒细胞集落刺激因子（G-CSF），包括非格司亭制剂后，可能出现毛细血管渗漏综合征（CLS），其特征为低血压、低白蛋白血症、水肿和血液浓缩。发作频率和严重程度各异，若治疗延误，可能危及生命。

.

。

Patients with symptoms should be closely monitored and receive appropriate treatment.

有症状的患者应接受密切监测并给予适当治疗。

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML):

骨髓增生异常综合征（MDS）和急性髓系白血病（AML）：

Patients with Severe Chronic Neutropenia (SCN

患有严重慢性中性粒细胞减少症（SCN）的患者

):

):

Confirm the diagnosis of SCN before initiating FILKRI therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN.

在开始 FILKRI 治疗之前，请确认严重慢性中性粒细胞减少症（SCN）的诊断。据报道，在未接受细胞因子治疗的先天性中性粒细胞减少症的自然病程中，可发生骨髓增生异常综合征（MDS）和急性髓系白血病（AML）。在接受非格司亭类产品治疗 SCN 的患者中，也观察到染色体核型异常、转化为 MDS 以及 AML。

Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings.

异常细胞遗传学和骨髓增生异常综合征（MDS）与最终发展为髓系白血病相关。非格司亭类产品对异常细胞遗传学发展的影响，以及在存在异常细胞遗传学或MDS的患者中持续使用非格司亭的影响尚不明确。在这些情况下，应监测患者是否出现MDS/急性髓系白血病（AML）的体征和症状。

If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing FILKRI should be carefully considered..

如果严重慢性中性粒细胞减少症（SCN）患者出现异常细胞遗传学或骨髓增生异常，应仔细权衡继续使用 FILKRI 的风险与获益。

Patients with Breast and Lung Cancer

乳腺癌和肺癌患者

:

：

MDS and AML have been associated with the use of filgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

在乳腺癌和肺癌患者中，非格司亭制剂与化疗和/或放疗联合使用已与骨髓增生异常综合征（MDS）和急性髓系白血病（AML）的发生相关。在这些情况下，应监测患者是否出现 MDS/AML 的体征和症状。

Thrombocytopenia:

血小板减少症：

Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts.

已有报告指出，接受非格司亭制剂治疗的患者会出现血小板减少症。应监测血小板计数。

Leukocytosis:

白细胞增多症：

Patients with Cancer Receiving Myelosuppressive Chemotherapy

接受骨髓抑制性化疗的癌症患者

:

：

White blood cell counts ≥ 100,000/mm

白细胞计数 ≥ 100,000/mm³

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were observed in about 2% of patients who received filgrastim products at dosages above 5 mcg/kg/day. Discontinue FILKRI if the absolute neutrophil count (ANC) surpasses 10,000/mm

在每日剂量超过 5 mcg/kg 接受非格司亭产品的患者中，约有 2% 观察到上述情况。如果绝对中性粒细胞计数（ANC）超过 10,000/mm³，请停用 FILKRI。

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after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy with FILKRI.

在化疗引起的中性粒细胞绝对计数（ANC）最低点出现后。在使用 FILKRI 治疗期间，每周至少监测两次全血细胞计数（CBC）。

Discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days.

停用非格司亭治疗通常导致循环中性粒细胞在1至2天内减少50%，并在1至7天内恢复至治疗前水平。

Cutaneous Vasculitis:

皮肤血管炎：

Moderate or severe cases of cutaneous vasculitis has been reported in patients treated with filgrastim products

在接受非格司亭产品治疗的患者中，已有中度或重度皮肤血管炎的报道。

.

。

Most reports involved patients with SCN receiving long-term filgrastim therapy

大多数报告涉及接受长期非格司亭治疗的严重慢性中性粒细胞减少症患者

.

。

Hold FILKRI therapy in patients with cutaneous vasculitis

在皮肤血管炎患者中暂停 FILKRI 治疗

.

。

FILKRI dose may be reduced when the symptoms resolve and the ANC has decreased.

当症状消退且绝对中性粒细胞计数（ANC）下降时，可减少FILKRI的剂量。

Potential Effect on Malignant Cells:

对恶性细胞的潜在影响：

FILKRI is a growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which FILKRI acts has also been found on tumor cell lines. The possibility that FILKRI acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established..

FILKRI是一种主要刺激中性粒细胞的生长因子。FILKRI作用的粒细胞集落刺激因子（G-CSF）受体也在肿瘤细胞系中被发现。不能排除FILKRI作为任何类型肿瘤的生长因子的可能性。非格司亭产品在慢性髓性白血病（CML）和骨髓增生异常综合征中的安全性尚未确立。

Simultaneous Use with Chemotherapy and Radiation Not Recommended:

不建议与化疗和放疗同时使用：

The safety and efficacy of FILKRI given simultaneously with cytotoxic chemotherapy and radiation have not been established

尚未确定 FILKRI 与细胞毒性化疗和放射治疗同时给药的安全性和有效性

.

。

Do not use FILKRI 24 hours before or after administration of cytotoxic chemotherapy

在给予细胞毒性化疗药物前后24小时内，不得使用FILKRI。

.

。

The safety and efficacy of FILKRI have not been evaluated in patients receiving concurrent radiation therapy

尚未在接受同步放射治疗的患者中评估 FILKRI 的安全性和有效性

.

。

Avoid the simultaneous use of FILKRI with chemotherapy and radiation therapy.

避免将 FILKRI 与化疗和放疗同时使用。

Nuclear Imaging:

核医学成像：

Increased hematopoietic activity of the bone marrow has been associated with transient positive bone-imaging changes on nuclear imaging.

骨髓造血活性增加与核医学成像中短暂的阳性骨显像改变相关。

Aortitis:

主动脉炎：

Aortitis has been reported in patients receiving filgrastim products

已有报告指出，接受非格司亭类产品治疗的患者出现了主动脉炎。

.

。

It may occur as early as the first week after start of therapy

可能在治疗开始后的第一周就出现

.

。

Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)

临床表现可能包括全身性体征和症状，如发热、腹痛、不适、背痛以及炎症标志物升高（例如C反应蛋白和白细胞计数）。

.

。

Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FILKRI if aortitis is suspected.

对于出现这些体征和症状但病因不明的患者，应考虑主动脉炎的可能性。若怀疑主动脉炎，应停用 FILKRI。

The most common adverse reactions in patients:

患者中最常见的不良反应：

with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs

患有非髓系恶性肿瘤并接受骨髓抑制性抗癌药物治疗的患者

(≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea

（与安慰剂相比，发生率差异≥5%）包括发热、疼痛、皮疹、咳嗽和呼吸困难

with AML

使用 AML

(≥ 2% difference in incidence) are pain, epistaxis and rash

（发生率差异≥2%）为疼痛、鼻出血和皮疹

with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT

患有非髓系恶性肿瘤并接受清髓性化疗随后进行骨髓移植的患者

(≥ 5% difference in incidence) is rash

（发生率差异 ≥ 5%）为皮疹

with severe chronic neutropenia (SCN)

患有严重慢性中性粒细胞减少症（SCN）

(≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia

（发生率差异≥5%）包括疼痛、贫血、鼻出血、腹泻、感觉减退和脱发

INDICATIONS

适应症

FILKRI is a leukocyte growth factor indicated to:

FILKRI 是一种白细胞生长因子，适用于：

Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever

降低接受骨髓抑制性抗癌药的非髓系恶性肿瘤患者中发热性中性粒细胞减少所表现的感染发生率，这些药物与显著的重度发热性中性粒细胞减少发生率相关

Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)

缩短急性髓系白血病（AML）患者在诱导或巩固化疗后中性粒细胞恢复的时间及发热持续时间

Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)

缩短接受清髓性化疗随后进行骨髓移植（BMT）的非髓系恶性肿瘤患者的中性粒细胞减少症持续时间及其中性粒细胞减少相关的临床后遗症（例如，发热性中性粒细胞减少症）

Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia

降低先天性中性粒细胞减少症、周期性中性粒细胞减少症或特发性中性粒细胞减少症的症状性患者中，严重中性粒细胞减少症后遗症（如发热、感染、口咽溃疡）的发生率和持续时间

Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)

提高急性暴露于骨髓抑制剂量辐射（急性放射综合征的造血综合征）患者的生存率

http://www.fda.gov/medwatch

http://www.fda.gov/medwatch

For more information, please see the

更多信息，请参见

full Prescribing Information

完整处方信息

.

。

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获取。

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® (pegfilgrastim); 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），一种NEULASTA®（聚乙二醇化非格司亭）的生物类似药；FILKRI™（filgrastim-laha），一种NEUPOGEN®（非格司亭）的生物类似药；IMULDOSA®（ustekinumab-srlf），一种STELARA®（乌司奴单抗）的生物类似药；HERCESSI™（trastuzumab-strf），一种HERCEPTIN®（曲妥珠单抗）的生物类似药；OSVYRTI®（denosumab-desu），一种Prolia®（地舒单抗）的生物类似药；JUBEREQ®（denosumab-desu），一种Xgeva®（地舒单抗）的生物类似药；ENNUMO™（pegfilgrastim-pccg），一种NEULASTA®（聚乙二醇化非格司亭）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

www.accordbiopharma.com

.

。

References:

参考文献：

FILKRI (filgrastim-laha) injection. Prescribing Information. Accord BioPharma.

FILKRI（非格司亭-laha）注射液。处方信息。Accord BioPharma。

UDENYCA Prescribing Information. Coherus BioSciences.

UDENYCA 处方信息。Coherus BioSciences 公司。

Cleveland Clinic. Neutropenia. Updated June 9, 2022. Accessed October 2, 2026.

克利夫兰诊所。中性粒细胞减少症。更新于2022年6月9日。访问于2026年10月2日。

https://my.clevelandclinic.org/health/diseases/21058-neutropenia

https://my.clevelandclinic.org/health/diseases/21058-neutropenia

.

。

Samsung Bioepis.

三星生物制剂

Biosimilar Market Report

生物类似药市场报告

. 13th ed., Q2 2026.

第13版，2026年第二季度。

All trademarks, logos and brand names are the property of their respective owners.

所有商标、徽标和品牌名称均归其各自所有者所有。

Contact:

联系方式：

[email protected]

[email protected]

SOURCE Accord BioPharma

来源：Accord BioPharma

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