美国食品药品监督管理局（FDA）授予Celltrion公司仿制Humira®（阿达木单抗）的生物类似药YUFLYMA®（阿达木单抗-aaty）可互换性指定-动脉网

U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab)

CISION 等信源发布 2025-04-15 08:51

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YUFLYMA

尤弗莱玛

(adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira

(adalimumab-aaty) 是一种高浓度（100mg/mL）且不含柠檬酸盐的Humira配方。

(adalimumab) biosimilar, that is now interchangeable

（阿达木单抗）生物类似药，现在可互换。

[1]

Interchangeable designation of YUFLYMA

YUFLYMA 的可互换名称

是

supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis

基于中度至重度斑块型银屑病患者III期互换性研究的积极数据支持

INCHEON,

仁川，

South Korea

韩国

，

April 14, 2025

2025年4月14日

/PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA

/PRNewswire/ -- Celltrion, Inc. 今天宣布，美国食品药品监督管理局 (FDA) 已指定 YUFLYMA

(adalimumab-aaty), as an interchangeable biosimilar to Humira

（阿达木单抗-aaty），作为与修美乐可互换的生物类似药

(adalimumab). YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira

（阿达木单抗）。YUFLYMA 是一种经 FDA 批准的高浓度（100mg/mL）且不含柠檬酸盐的 Humira 制剂。

biosimilar, approved for multiple inflammatory indications.

生物类似药，获批用于多种炎症适应症。

[1]

'With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need,' said

“随着这一新的指定，YUFLYMA 更加能够帮助更多患者获得并负担他们所需的治疗，”

Thomas Nusbickel

托马斯·努斯比克尔

, Chief Commercial Officer at Celltrion

Celltrion首席商务官

USA

美国

. 'YUFLYMA has the same dosage form, route of administration, and dosing regimen as the reference product. The pharmacist's ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab.'.

“YUFLYMA与原研产品具有相同的剂型、给药途径和剂量方案。药剂师能够在药房直接替换生物类似药，无需新处方的麻烦，也不需要患者学习新的给药方法，这可能会成为增加患者获取阿达木单抗的关键转折点。”

The interchangeable designation was supported by data from the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Week 25-27.

三期可互换性研究的数据支持了这种可互换的指定，该研究显示，在中度至重度斑块型银屑病患者中，持续接受参考药物阿达木单抗（ADA）治疗的患者与在第25至27周剂量间隔期间交替使用参考药物ADA和YUFLYMA的患者，在药代动力学、疗效、安全性和免疫原性方面的结果相似。

The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV) 2024..

互换性研究的结果在2024年欧洲皮肤病与性病学会（EADV）上公布。

[2]

FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider, subject to state laws.

根据州法律，FDA批准的可互换生物类似药可以在药房替代参照产品，而无需开具处方的医疗保健提供者介入。

[3]

The high-concentration form of YUFLYMA was FDA-approved in

YUFLYMA 的高浓度形式获得了 FDA 批准。

May 2023

2023年5月

and is currently available as 20mg, 40 mg and 80mg solution for injection in a prefilled syringe and in an autoinjector pen. YUFLYMA was introduced into the US commercial market on

目前有20毫克、40毫克和80毫克注射液，预充式注射器和自动注射笔两种形式供应。YUFLYMA已于美国商业市场推出。

July 2, 2023

2023年7月2日

。

YUFLYMA is available in two pricing options to help provide more affordable options for patients. Adalimumab-aaty, the unbranded version, is priced at an 85% discount to the current wholesale acquisition cost (WAC) list price of Humira (adalimumab), providing economic benefits for patients and overall healthcare system.

YUFLYMA 提供两种定价选项，以帮助为患者提供更实惠的选择。无品牌版本的阿达木单抗-aaty 定价比当前 Humira（阿达木单抗）的批发收购成本 (WAC) 价格低 85%，为患者和整体医疗系统带来经济利益。

The branded version is priced at a 5% discount to the current WAC of Humira (adalimumab)..

品牌版本的价格比当前Humira（阿达木单抗）的WAC低5%。

Notes to Editors:

编辑注意：

About YUFLYMA

关于YUFLYMA

(CT-P17, biosimilar adalimumab-aaty)

（CT-P17，生物类似药阿达木单抗-aaty）

[1]

YUFLYMA is the world's first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

YUFLYMA 是全球首个获得欧盟委员会批准的高浓度、小剂量且不含柠檬酸盐的阿达木单抗生物类似药。YUFLYMA 已获 FDA 批准用于治疗类风湿性关节炎、幼年特发性关节炎、银屑病关节炎、强直性脊柱炎、克罗恩病、溃疡性结肠炎、斑块状银屑病、化脓性汗腺炎和葡萄膜炎患者。

YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL..

YUFLYMA已被FDA指定为可互换的生物类似药，采用预充式注射器。YUFLYMA是一种重组全人源抗肿瘤坏死因子α（抗-TNFα）单克隆抗体。YUFLYMA有20mg/0.2mL、40mg/0.4mL和80mg/0.8mL规格可供使用。

IMPORTANT SAFETY INFORMATION

重要安全信息

[1]

This important safety information also applies to YUFLYMA

这一重要的安全信息同样适用于YUFLYMA

(adalimumab-aaty)

(阿达利姆单抗-aaty)

SERIOUS INFECTIONS

严重感染

Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

使用阿达木单抗-aaty治疗的患者感染严重疾病的风险增加，这可能导致住院或死亡。大多数发生这些感染的患者同时服用了免疫抑制剂，如甲氨蝶呤或皮质类固醇。

Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis.

如果患者出现严重感染或败血症，应停止使用阿达木单抗-aaty。

Reported infections include:

报告的感染包括：

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use.

活动性结核病（TB），包括潜伏性结核的再激活。结核病患者常表现为播散性或肺外疾病。在使用阿达木单抗-aaty之前和治疗期间，应检测患者是否存在潜伏性结核。在使用阿达木单抗-aaty之前，开始对潜伏性结核进行治疗。

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

侵袭性真菌感染，包括组织胞浆菌病、球孢子菌病、念珠菌病、曲霉病、芽生菌病和肺孢子虫病。患有组织胞浆菌病或其他侵袭性真菌感染的患者可能表现为播散性疾病，而非局部疾病。在一些活动性感染的患者中，组织胞浆菌病的抗原和抗体检测可能呈阴性。

Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness..

考虑对有侵袭性真菌感染风险且出现严重全身性疾病的患者进行经验性抗真菌治疗。

Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

细菌、病毒和其他由于机会性病原体（包括军团菌和李斯特菌）引起的感染。

Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection.

在开始对慢性或反复感染的患者进行治疗之前，应仔细考虑使用阿达利姆单抗-aaty治疗的风险和益处。

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

在使用阿达木单抗-aaty治疗期间及治疗后，密切监测患者是否出现感染的迹象和症状，包括在开始治疗前潜伏性结核病检测为阴性的患者中可能出现的结核病。

Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections.

阿达利姆单抗-aaty 不应用于活动性感染（包括局部感染）的患者。

Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy..

65岁以上的患者、有合并症的患者和/或服用伴随免疫抑制剂（如皮质类固醇或甲氨蝶呤）的患者可能面临更高的感染风险。如果患者出现严重感染或败血症，应停止使用阿达木单抗-aaty。对于在使用阿达木单抗-aaty治疗期间发生新感染的患者，应密切监测，迅速进行全面的诊断评估（适合免疫功能低下的患者），并开始适当的抗菌治疗。

Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA.

生物制品的药物相互作用：在类风湿关节炎（RA）患者的临床研究中，观察到肿瘤坏死因子（TNF）阻滞剂与阿那白滞素或阿巴西普联用时，严重感染的风险增加，且无额外益处；因此，不建议类风湿关节炎患者将阿达木单抗-aaty与阿巴西普或阿那白滞素联合使用。

A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS.

在接受利妥昔单抗治疗的RA患者中，随后使用TNF阻滞剂治疗时也观察到较高的严重感染发生率。关于同时使用阿达木单抗-aaty和其他生物制品治疗RA、PsA、AS、CD、UC、PS和HS的信息不足。

Concomitant administration of adalimumab-aaty with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker..

基于可能增加的感染风险及其他潜在的药理相互作用，不建议将阿达木单抗-aaty与其他生物类DMARD（如阿那白滞素和阿巴西普）或其他TNF抑制剂同时使用。在使用利妥昔单抗治疗后接受TNF抑制剂后续治疗的RA患者中，观察到严重感染的发生率较高。

MALIGNANCY

恶性肿瘤

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products.

在接受肿瘤坏死因子（TNF）抑制剂治疗的儿童和青少年患者中，包括阿达木单抗产品，已有报告发生淋巴瘤和其他恶性肿瘤，其中一些病例为致命的。在上市后监测中，也发现接受TNF抑制剂治疗的患者，包括阿达木单抗产品，出现肝脾T细胞淋巴瘤（HSTCL）这种罕见类型的T细胞淋巴瘤。

These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis.

这些病例的病程非常严重，并且是致命的。大多数报告的TNF阻滞剂病例发生在克罗恩病或溃疡性结肠炎患者中，其中大多数为青少年和年轻成年男性。几乎所有这些患者在诊断时或之前都同时接受了硫唑嘌呤或6-巯基嘌呤与TNF阻滞剂的联合治疗。

It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants..

目前尚不确定HSTCL的发生是否与使用TNF阻滞剂或TNF阻滞剂与这些其他免疫抑制剂的联合使用有关。

Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.

在已知患有非成功治疗的非黑色素瘤皮肤癌（NMSC）以外的恶性肿瘤患者中开始治疗前，或在考虑继续使用TNF抑制剂（包括阿达木单抗-aaty）治疗期间若患者出现恶性肿瘤时，应权衡TNF抑制剂治疗的风险和益处。

In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.

在某些阿达木单抗产品的临床试验的受控部分中，与接受对照治疗的成年患者相比，观察到更多恶性肿瘤病例。

Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients.

在使用阿达木单抗产品治疗的患者中，临床试验期间报告了非黑色素瘤皮肤癌（NMSC）。在39项全球阿达木单抗临床试验的对照阶段中，涉及成年RA、PsA、AS、CD、UC、PS、HS和UV患者，阿达木单抗治疗组的非黑色素瘤皮肤癌发生率为0.8（0.52, 1.09）每100患者年，而对照组的发生率为0.2（0.10, 0.59）每100患者年。

Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty..

在使用阿达利姆单抗-aaty治疗前和治疗期间，检查所有患者，特别是那些有既往长期免疫抑制治疗史或有PUVA治疗史的银屑病患者，是否出现非黑色素瘤皮肤癌（NMSC）。

In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers..

在某些阿达木单抗产品的临床试验中，淋巴瘤的发生率比美国普通人群预期的高出约三倍。患有类风湿性关节炎（RA）和其他慢性炎症疾病的患者，特别是那些疾病高度活跃和/或长期暴露于免疫抑制疗法的患者，即使在没有TNF阻滞剂的情况下，其发生淋巴瘤的风险可能比普通人群高出数倍。

Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents..

使用TNF抑制剂治疗RA及其他适应症时，报告了急性及慢性白血病的上市后病例。在接受阿达木单抗治疗的儿童、青少年和年轻成人中，约一半的上市后恶性肿瘤病例为淋巴瘤；其他病例则包含多种不同的恶性肿瘤，其中包括通常与免疫抑制相关的罕见恶性肿瘤，以及通常在儿童和青少年中不常见的恶性肿瘤。

HYPERSENSITIVITY

超敏反应

Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy.

已有报告指出，在使用阿达木单抗产品后会出现过敏反应和血管性水肿。如果发生过敏性或其他严重过敏反应，应立即停止使用阿达木单抗-aaty并采取适当的治疗。

HEPATITIS B VIRUS REACTIVATION

乙型肝炎病毒再激活

Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

使用包括阿达木单抗-aaty在内的TNF阻滞剂，可能会增加慢性携带者患者乙肝病毒（HBV）重新激活的风险。在某些情况下，与TNF阻滞剂治疗同时发生的HBV重新激活可能是致命的。

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

在开始TNF阻滞剂治疗前，评估有HBV感染风险的患者是否有既往HBV感染的证据。

Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.

对被确定为HBV携带者的患者开具TNF阻滞剂时应谨慎，并在治疗期间及治疗结束后的数月内密切监测此类患者的临床和实验室活动性HBV感染迹象。

In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely..

在发生HBV再激活的患者中，停止使用阿达木单抗-aaty，并启动有效的抗病毒治疗及适当的辅助治疗。在HBV再激活得到控制后恢复TNF抑制剂治疗的安全性尚不清楚。因此，在这种情况下考虑重新开始阿达木单抗-aaty治疗时应谨慎，并密切监测患者。

NEUROLOGIC REACTIONS

神经系统反应

Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome..

使用包括阿达木单抗产品在内的TNF阻断剂，与罕见的中枢神经系统脱髓鞘疾病（如多发性硬化症（MS）和视神经炎）以及周围神经系统脱髓鞘疾病（如格林-巴利综合征）的新发或临床症状加重及/或影像学证据有关。

Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop.

对于既往存在或近期发作的中枢或周围神经系统脱髓鞘疾病的患者，考虑使用阿达木单抗-aaty时应谨慎；如果出现任何此类疾病，应考虑停用阿达木单抗-aaty。

There is a known association between intermediate uveitis and central demyelinating disorders.

中间葡萄膜炎与中枢脱髓鞘疾病之间存在已知的关联。

HEMATOLOGIC REACTIONS

血液学反应

Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.

使用TNF阻断剂的患者中已有极少数出现全血细胞减少症（包括再生障碍性贫血）的报告。

Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.

包括医学上显著的细胞减少症在内的血液系统不良反应，在使用阿达木单抗产品的患者中很少被报告。

Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities.

考虑在确诊有显著血液学异常的患者中停用阿达木单抗-aaty治疗。

HEART FAILURE

心力衰竭

Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.

已有报告指出，使用TNF抑制剂会导致充血性心力衰竭（CHF）恶化和新发CHF的病例。同时，使用阿达木单抗产品也观察到CHF恶化的病例。

Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully.

在心力衰竭患者中使用阿达木单抗-aaty时应谨慎，并仔细监测他们。

AUTOIMMUNITY

自身免疫性疾病

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment.

使用阿达木单抗产品治疗可能会导致自身抗体的形成，并且在极少数情况下会发展为类似狼疮综合征的症状。如果患者在接受阿达木单抗-aaty治疗后出现类似狼疮综合征的症状，应停止治疗。

IMMUNIZATIONS

免疫接种

Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines.

接受阿达利单抗-aaty治疗的患者可以同时接种疫苗，但活疫苗除外。

It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy.

建议如果可能的话，儿科患者在开始阿达木单抗-aaty治疗之前，按照当前的免疫指南，接受所有疫苗接种。

No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.

对于接受阿达木单抗产品的患者，目前尚无关于活疫苗继发感染传播的数据。

The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab

在接触过阿达木单抗的婴儿中接种活疫苗或减毒活疫苗的安全性

in utero

子宫内

is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

未知。在给（活疫苗或减毒活疫苗）暴露的婴儿接种前，应权衡风险和益处。

ADVERSE REACTIONS

不良反应

The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

阿达木单抗临床试验中最常见的不良反应（>10%）包括：感染（如上呼吸道感染、鼻窦炎）、注射部位反应、头痛和皮疹。

INDICATIONS

适应症

Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for:

阿达利姆单抗-aaty是一种肿瘤坏死因子（TNF）阻滞剂，适用于：

Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA

类风湿关节炎 (RA)：减轻中度至重度活动性 RA 成人患者的症状和体征，诱导主要临床反应，抑制结构性损伤的进展，并改善身体功能。

Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older

幼年特发性关节炎 (JIA)：减少2岁及以上中度至重度活动性多关节型JIA患者的症状和体征。

Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA

银屑病关节炎 (PsA)：减轻活动性 PsA 成人患者的症状和体征，抑制结构损伤的进展，并改善身体功能。

Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS

强直性脊柱炎 (AS)：减轻活动性AS成年患者的症状和体征

Crohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older

克罗恩病 (CD)：用于治疗中度至重度活动性克罗恩病，适用于成人及6岁及以上儿科患者。

Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults

溃疡性结肠炎 (UC)：用于治疗中度至重度活动性溃疡性结肠炎的成人患者

Limitations of Use:

使用限制：

Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers

对TNF阻滞剂失去反应或不耐受的患者，其有效性尚未确定。

Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

斑块型银屑病（Ps）：适用于中度至重度慢性斑块型银屑病的成年患者，这些患者适合接受系统治疗或光疗，且其他系统治疗在医学上不太适用时。

Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa

脓疱性汗腺炎（HS）：用于治疗中度至重度脓疱性汗腺炎的成年患者

Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

葡萄膜炎（UV）：用于治疗成年患者非感染性的中间、后部和全葡萄膜炎

For Yuflyma (adalimumab-aaty):

对于尤氟玛（阿达利姆单抗-aaty）：

Please click for Full U.S. Prescribing Information.

请点击查看完整的美国处方信息。

For adalimumab-aaty:

对于阿达木单抗-aaty：

Please see Full U.S. Prescribing Information.

请参阅完整的美国处方信息。

Globally, prescribing information varies; refer to the individual country product label for complete information.

全球范围内，处方信息各不相同；欲了解完整信息，请参阅各个国家的产品标签。

About Celltrion

关于Celltrion

, Inc.

有限公司

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，这些疗法改善了全世界人民的生活。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了多个治疗领域，包括免疫学、肿瘤学、血液学、眼科和内分泌学。除了生物类似药产品外，我们还致力于通过创新药物推进研发管线，突破科学创新的界限，提供高质量的药物。

For more information, please visit our website .

欲了解更多信息，请访问我们的网站。

www.celltrion.com/en-us

www.celltrion.com/zh-cn

and stay updated with our latest news and events on our social media:

并通过我们的社交媒体关注我们的最新消息和活动：

领英

，

Instagram

，

, and

，以及

Facebook

。

About Celltrion

关于Celltrion

USA

美国

Celltrion

细胞生物公司

USA

美国

is Celltrion's U.S. subsidiary established in 2018. Headquartered in

是Celltrion于2018年成立的美国子公司，总部位于

New Jersey

新泽西州

, Celltrion

，Celltrion

USA

美国

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

致力于扩大美国患者获得创新生物制剂的机会，以改善护理。Celltrion在免疫学、肿瘤学、血液学和内分泌学领域获得FDA批准的生物类似药产品包括：INFLECTRA。

(infliximab-dyyb), TRUXIMA

（英夫利昔单抗-dyyb），TRUXIMA

(rituximab-abbs), HERZUMA

（利妥昔单抗-abbs），赫赛汀

(trastuzumab-pkrb), VEGZELMA

（曲妥珠单抗-pkrb），VEGZELMA

(bevacizumab-adcd), YUFLYMA

（贝伐珠单抗-adcd），YUFLYMA

(adalimumab-aaty), AVTOZMA

(阿达木单抗-aaty)，AVTOZMA

(tocilizumab-anho), STEQEYMA

（托珠单抗-anho），STEYEYMA

(ustekinumab-stba), STOBOCLO

(乌司奴单抗-stba)，STOBOCLO

(denosumab-bmwo), OSENVELT

(denosumab-bmwo)，OSENVELT

(denosumab-bmwo) and OMLYCLO

(denosumab-bmwo) 和 OMLYCLO

(omalizumab-igec), as well as the novel biologic ZYMFENTRA

（奥马珠单抗-igec），以及新型生物制剂ZYMFENTRA

(infliximab-dyyb). Celltrion

（英夫利昔单抗-dyyb）。Celltrion

USA

美国

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

将继续利用Celltrion在生物技术领域的独特优势、卓越的供应链能力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

and stay updated with our latest news and events on our social media:

并通过我们的社交媒体了解我们的最新消息和活动：

领英

。

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. This press release contains forward looking statements.

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，这些陈述可能构成相关证券法下的前瞻性陈述。本新闻稿包含前瞻性陈述。

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', 'anticipate' the negative of these words or such other variations thereon or comparable terminology..

这些陈述也可能通过诸如“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”、“以...为目标”、“或许”、“一旦确定”、“将”、“朝着...努力”、“预定”、“可供使用”、“有潜力”、“预期”等词语或其否定形式、其他变化形式或类似术语来识别。

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 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..

前瞻性陈述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。这些陈述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的风险及不确定性，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, Inc. 及其子公司在情况或管理层的估计或意见发生变化时，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

Humira is a registered trademark of AbbVie.

Humira 是 AbbVie 的注册商标。

YUFLYMA

羽飞立马

is a registered trademark of Celltrion, Inc., used under license.

是Celltrion公司的注册商标，经许可使用。

References

参考文献

[1] YUFLYMA US prescribing information (2023)

[1] YUFLYMA美国处方信息（2023）

[2] Lebwohl M et al., Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-toSevere Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study.

[2] Lebwohl M 等，中度至重度斑块型银屑病患者多次从参照阿达木单抗转换为阿达木单抗生物类似药（CT-P17）后的药代动力学、有效性和安全性与维持组（参照阿达木单抗）的比较：III 期互换性研究的第 27 周结果。

[EADV 2024, Poster number P0931]. Available at:.

[EADV 2024，海报编号 P0931]。可用地址：。

https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2024/41489.pdf

[3] 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Available at :

[3] 关于生物类似药和可互换生物类似药的9个须知事项。可用链接：

https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

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