Ustekinumab biosimilar (Accord BioPharma)

Prefilled syringes (PFS) preferred on pharmacy benefit; vials preferred on medical benefit 预填充注射器（PFS）在药房福利中更受青睐；药瓶在医疗福利中更受青睐。RALEIGH, N.C. 北卡罗来纳州罗利市, ，April 20, 2026 2026年4月20日/PRNewswire/ -- /PRNewswire/ --Accord BioPharma 雅阁生物制药, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology and immunology therapies, announced IMULDOSA® (ustekinumab-srlf) is now covered by Cigna Healthcare, effective April 15, 2026. 美国Intas Pharmaceuticals, Ltd.的专科部门，专注于肿瘤学和免疫学疗法的开发，宣布IMULDOSA®（ustekinumab-srlf）自2026年4月15日起将由Cigna Healthcare承保。IMULDOSA, a biosimilar to STELARA® (ustekinumab), is approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis in adults, as well as pediatric indications for plaque psoriasis and psoriatic arthritis.. IMULDOSA，一种与STELARA®（乌司奴单抗）相似的生物仿制药，被批准用于治疗中度至重度斑块状银屑病、活动性银屑病关节炎、中度至重度活动性克罗恩病以及中度至重度活动性溃疡性结肠炎的成人患者，同时也适用于斑块状银屑病和银屑病关节炎的儿科适应症。1 1The FDA approved IMULDOSA in October 2024. Please see below for Important Safety Information. 美国食品药品监督管理局（FDA）于2024年10月批准了IMULDOSA。以下是重要的安全信息。'This coverage decision represents meaningful progress in our mission to become a leader within the U.S. biosimilar industry,' said Chrys Kokino, President of Accord North America. 'Every formulary win brings us closer to ensuring cost isn't a barrier for patients to access proven biologic therapies for urgent and critical medical conditions.'. “这一覆盖决定代表着我们在成为美国生物仿制药行业领导者使命中取得了有意义的进展，”Accord北美区总裁Chrys Kokino表示。“每一次处方集的胜利都让我们离确保患者不会因成本问题而无法获得针对紧急和关键医疗状况的成熟生物疗法更近一步。”Preferred formulary status provides patients and healthcare providers with streamlined access to IMULDOSA across both pharmacy and medical benefit coverage. 首选的处方集地位为患者和医疗保健提供者提供了在药房和医疗福利覆盖范围内的简化获取IMULDOSA的途径。Effective April 15, 2026, coverage includes: 自2026年4月15日起，覆盖范围包括：IMULDOSA prefilled syringes — Preferred on all Cigna Healthcare commercial pharmacy benefit drug lists IMULDOSA预充式注射器——在所有信诺医疗商业药房福利药品清单上优先选用IMULDOSA vials — Preferred on the Cigna Healthcare commercial medical benefit IMULDOSA小瓶——在Cigna Healthcare商业医疗福利中优先选用Patients and providers should confirm individual plan benefits with their plan administrator or benefits manager. 患者和提供者应与他们的计划管理员或福利经理确认个人计划福利。In addition to Cigna, IMULDOSA is included on Express Scripts' largest commercial formularies, including the National Preferred Formulary, effective September 5, 2025. 除了信诺（Cigna）之外，IMULDOSA 还被列入快捷药方（Express Scripts）最大的商业处方集，包括国家首选处方集，自2025年9月5日起生效。For more details, please visit 欲了解更多信息，请访问www.imuldosa.com/ www.imuldosa.com/. 。Contact: 联系人：[email protected] [email protected]IMPORTANT SAFETY INFORMATION 重要安全信息 IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in IMULDOSA. IMULDOSA 禁用于对乌司奴单抗产品或 IMULDOSA 中任何辅料有临床显著过敏反应的患者。Infections 感染Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. 乌司奴单抗产品可能会增加感染和潜伏感染再激活的风险。在接受乌司奴单抗产品的患者中观察到严重的细菌、分枝杆菌、真菌和病毒感染。Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: 在临床试验中报告的需要住院治疗或具有其他临床意义的严重感染包括以下内容：Plaque psoriasis: 斑块状银屑病：diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. 憩室炎、蜂窝织炎、肺炎、阑尾炎、胆囊炎、败血症、骨髓炎、病毒感染、胃肠炎和尿路感染。 Psoriatic arthritis: 银屑病关节炎：cholecystitis. 胆囊炎。Crohn's disease: 克罗恩病：anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. 肛周脓肿、胃肠炎、眼带状疱疹、肺炎和李斯特菌脑膜炎。Ulcerative colitis: 溃疡性结肠炎：gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. 胃肠炎、眼部带状疱疹、肺炎和李斯特菌病。Avoid initiating treatment with IMULDOSA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of IMULDOSA in patients with a chronic infection or a history of recurrent infection.. 在任何临床上重要的活动性感染得到解决或充分治疗之前，避免使用IMULDOSA进行治疗。对于慢性感染或反复感染病史的患者，在开始使用IMULDOSA之前，应权衡治疗的风险和益处。Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with IMULDOSA and discontinue IMULDOSA for serious or clinically significant infections until the infection resolves or is adequately treated. 指导患者在使用IMULDOSA治疗期间，如果出现提示感染的体征或症状，应寻求医疗建议，并且对于严重或临床显著的感染，应停止使用IMULDOSA，直到感染消退或得到适当治疗。 Theoretical Risk for Vulnerability to Particular Infections 特定感染易感性的理论风险Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.. 遗传性IL-12/IL-23缺乏的个体对分枝杆菌（包括非结核性环境分枝杆菌）、沙门氏菌（包括非伤寒株）和卡介苗（BCG）接种的播散性感染特别易感。此类患者已报告出现严重感染和致命后果。It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). 目前尚不清楚使用乌司奴单抗产品进行IL-12/IL-23药理学阻断的患者是否容易感染这些类型的疾病。考虑进行适当的诊断测试（例如，组织培养、粪便培养，根据临床情况决定）。Pre-treatment Evaluation for Tuberculosis 结核病的预处理评估Evaluate patients for tuberculosis infection prior to initiating treatment with IMULDOSA. Avoid administering IMULDOSA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering IMULDOSA. Consider anti-tuberculosis therapy prior to initiation of IMULDOSA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. 在开始使用IMULDOSA治疗前，应对患者进行结核感染评估。避免对活动性结核感染的患者使用IMULDOSA。在给予IMULDOSA之前，应先开始治疗潜伏性结核。对于有潜伏性或活动性结核病史且无法确认已接受足够疗程的患者，在开始使用IMULDOSA前应考虑抗结核治疗。Closely monitor patients receiving IMULDOSA for signs and symptoms of active tuberculosis during and after treatment.. 密切监测接受IMULDOSA治疗的患者在治疗期间及治疗后是否有活动性结核病的症状和体征。Malignancies 恶性肿瘤Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. 乌司奴单抗产品属于免疫抑制剂，可能会增加恶性肿瘤的风险。在临床试验中，接受乌司奴单抗治疗的受试者中有报告出现恶性肿瘤。在啮齿动物模型中，抑制IL-12/IL-23p40增加了恶性肿瘤的风险。The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. 乌司奴单抗产品在有恶性肿瘤病史或已知患有恶性肿瘤的患者中的安全性尚未得到评估。There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving IMULDOSA for the appearance of non-melanoma skin cancer. 已有接受乌司奴单抗产品的患者在存在非黑色素瘤皮肤癌风险因素的情况下，迅速出现多发性皮肤鳞状细胞癌的上市后报告。对所有接受IMULDOSA治疗的患者进行非黑色素瘤皮肤癌的监测。Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment.. 密切跟踪60岁以上患者、有长期免疫抑制治疗史的患者以及有PUVA治疗史的患者。Serious Hypersensitivity Reactions 严重过敏反应Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, discontinue IMULDOSA immediately and initiate appropriate medical treatment. 已有报告显示乌司奴单抗产品会引起严重的超敏反应，包括过敏反应和血管性水肿。如果发生过敏反应或其他具有临床意义的超敏反应，请立即停止使用IMULDOSA并开始适当的医疗处理。Posterior Reversible Encephalopathy Syndrome (PRES) 后部可逆性脑病综合征 (PRES)Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. 在临床试验中报告了两例后部可逆性脑病综合征（PRES），也称为可逆性后部白质脑病综合征（RPLS）。在银屑病、银屑病关节炎和克罗恩病患者的上市后使用中也有病例报告。临床表现包括头痛、癫痫发作、意识模糊、视觉障碍，以及在使用乌司奴单抗产品开始后的数天至数月内出现与PRES一致的影像学改变。A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.. 少数病例报告称延迟一年或更长时间。患者在停用乌司奴单抗产品后通过支持性护理恢复。Monitor all patients treated with IMULDOSA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue IMULDOSA. 监测所有接受IMULDOSA治疗的患者是否出现PRES的体征和症状。如果怀疑PRES，立即给予适当治疗并停用IMULDOSA。Immunizations 免疫接种Prior to initiating therapy with IMULDOSA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with IMULDOSA should not receive live vaccines. Avoid administering BCG vaccines during treatment with IMULDOSA or for one year prior to initiating treatment or one year following discontinuation of treatment. 在开始使用IMULDOSA治疗之前，患者应根据现行免疫指南接受所有适龄的免疫接种。接受IMULDOSA治疗的患者不应接种活疫苗。在使用IMULDOSA治疗期间，或在开始治疗前一年及停止治疗后一年内，应避免接种卡介苗（BCG）。Caution is advised when administering live vaccines to household contacts of patients receiving IMULDOSA because of the potential risk for shedding from the household contact and transmission to patient.. 由于家庭接触者可能脱落疫苗病毒并传播给患者，因此建议在接受IMULDOSA治疗的患者的家人接种活疫苗时要谨慎。Non-live vaccinations received during a course of IMULDOSA may not elicit an immune response sufficient to prevent disease. 在使用IMULDOSA期间接种的非活疫苗可能无法产生足够的免疫反应来预防疾病。Noninfectious Pneumonia 非感染性肺炎Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. 在乌司奴单抗产品上市后使用期间，已有报告间质性肺炎、嗜酸性肺炎和隐源性机化性肺炎的病例。临床表现包括在一至三剂用药后出现咳嗽、呼吸困难和间质浸润。严重后果包括呼吸衰竭和长期住院。Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue IMULDOSA and institute appropriate treatment.. 患者在停止治疗后有所改善，某些情况下使用皮质类固醇后也得到改善。如果诊断确认，请停止使用IMULDOSA并进行适当治疗。Most Common Adverse Reactions 最常见的不良反应The most common adverse reactions associated with ustekinumab products are: 与乌司奴单抗产品相关的最常见的不良反应是：Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue 银屑病和银屑病关节炎（≥3%）：鼻咽炎、上呼吸道感染、头痛和疲劳Crohn's Disease, induction (≥3%): vomiting 克罗恩病，诱导（≥3%）：呕吐Crohn's Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis 克罗恩病，维持治疗（≥3%）：鼻咽炎、注射部位红斑、外阴阴道念珠菌病/真菌感染、支气管炎、瘙痒、尿路感染和鼻窦炎Ulcerative colitis, induction (≥3%): nasopharyngitis 溃疡性结肠炎，诱导（≥3%）：鼻咽炎Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea 溃疡性结肠炎，维持治疗（≥3%）：鼻咽炎、头痛、腹痛、流感、发热、腹泻、鼻窦炎、疲劳和恶心Drug Interactions 药物相互作用Upon initiation or discontinuation of IMULDOSA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and adjust the individual dosage of the CYP substrate as needed. 在开始或停止使用IMULDOSA时，对于同时接受CYP450底物药物治疗的患者，特别是那些治疗指数狭窄的药物，应考虑监测治疗效果或药物浓度，并根据需要调整CYP底物的个体剂量。INDICATIONS 适应症IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: IMULDOSA 是一种人类白细胞介素-12 和 -23 拮抗剂，用于治疗：Adult patients 成人患者with: 包含：moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy 中度至重度斑块型银屑病（PsO），适合接受光疗或系统治疗的患者active psoriatic arthritis (PsA) 活动性银屑病关节炎 (PsA)moderately to severely active Crohn's disease (CD) 中度至重度活动性克罗恩病 (CD)moderately to severely active ulcerative colitis 中度至重度活动性溃疡性结肠炎Pediatric patients 儿科患者6 years and older with: 6岁及以上，具有：moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy 中度至重度斑块型银屑病（PsO），适合接受光疗或系统治疗的患者active psoriatic arthritis (PsA) 活动性银屑病关节炎 (PsA)To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or 要报告可疑的不良反应，请联系Accord BioPharma Inc，电话：1-866-941-7875，或FDA，电话：1-800-FDA-1088，或访问www.fda.gov/medwatch www.fda.gov/medwatch. 。IMULDOSA is supplied as single-dose prefilled syringes for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths or as a single-dose vial for intravenous infusion in 130 mg/26 mL (5 mg/mL) strength. IMULDOSA 提供了45 mg/0.5 mL 和 90 mg/mL 的单剂量预填充皮下注射器，或130 mg/26 mL（5 mg/mL）的单剂量静脉输注瓶。For more information, please see the 有关更多信息，请参见full Prescribing Information and Medication Guide 完整的处方信息和药物指南. 。About Accord BioPharma 关于Accord BioPharmaAccord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide more affordable, accessible, patient-centric therapies in oncology and immunology. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma, Inc. 是 Intas Pharmaceuticals, Ltd. 的美国专业部门，致力于在肿瘤学和免疫学领域提供更实惠、更易获得、以患者为中心的治疗方案。Accord BioPharma 专注于改善患者体验，超越药物的生物学本身，从患者的角度看待疾病，并开发对患者生活产生影响的高质量疗法。Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry, with a bold goal to launch 20 biosimilars by the year 2030. For more information, visit . Accord BioPharma相信生物类似药能够增加患者获得治疗的机会和选择，同时为美国医疗保健系统节省开支，并努力提供业内最丰富的生物类似药产品组合之一，目标是在2030年前推出20种生物类似药。欲了解更多信息，请访问。AccordBioPharma.com AccordBioPharma.com. 。References: 参考文献： IMULDOSA (ustekinumab-srlf). Prescribing Information. Accord BioPharma. IMULDOSA（乌司奴单抗-srlf）。处方信息。Accord BioPharma。All trademarks, logos and brand names are the property of their respective owners. 所有商标、徽标和品牌名称均为其各自所有者的财产。SOURCE Accord BioPharma 来源：Accord BioPharma21 21% %more press release views with 更多新闻稿浏览量与 Request a Demo 请求演示