INCHEON, South Korea, April 14, 2025 /-- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated

韩国仁川，2025年4月14日 /-- Celltrion公司今天宣布，美国食品药品监督管理局（FDA）已指定

Yuflyma

尤芙莉玛

(

(

adalimumab

阿达木单抗

-aaty), as an interchangeable biosimilar to

-aaty），作为一个可互换的生物类似药

Humira

修美乐

(adalimumab). Yuflyma is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications.[1]

（阿达木单抗）。Yuflyma 是一种获得 FDA 批准的高浓度（100mg/mL）且不含柠檬酸盐的 Humira® 生物类似药制剂，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 Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. 'Yuflyma has the same dosage form, route of administration, and dosing regimen as the reference product.

“随着这一新的认定，优福利玛将进一步帮助更多患者获得并负担得起他们所需的治疗，”Celltrion美国分公司首席商务官托马斯·努斯比克尔表示。“优福利玛与参照药品具有相同的剂型、给药途径和剂量方案。”

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.'.

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，这可能会改变游戏规则，增加患者获得阿达木单抗的机会。

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命名，该研究表明，在中度至重度活动性斑块状银屑病患者中，持续接受参照阿达木单抗（ADA）治疗的患者与在第25至27周剂量间隔期间交替使用参照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.[2] .

interchangeability 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.[3]

FDA批准的可互换生物类似药可以在药房替代参照产品，无需开具处方的医疗保健提供者介入，但需遵守州法律。[3]

The high-concentration form of Yuflyma was FDA-approved in May 2023 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 July 2, 2023.

2023年5月，高浓度的Yuflyma获得FDA批准，目前以预填充注射器和自动注射笔形式提供20mg、40mg和80mg的注射溶液。Yuflyma于2023年7月2日进入美国商业市场。

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。Adalimumab-aaty 是未贴牌版本，价格较当前 Humira（阿达木单抗）的批发采购成本 (WAC) 列表价享有 85% 的折扣，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)..

品牌版本的价格比目前Humira（阿达木单抗）的WAC低5%。

About Yuflyma (CT-P17, biosimilar adalimumab-aaty)

关于尤氟玛（CT-P17，生物类似药阿达木单抗-aaty）

[1]

[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.

尤氟玛是世界上首个获得欧洲委员会批准的高浓度、小剂量且不含柠檬酸的阿达木单抗生物类似药。尤氟玛已获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[1]

重要的安全信息[1]

This important safety information also applies to Yuflyma

这一重要的安全信息也适用于Yuflyma。

(adalimumab-aaty)

（阿达木单抗-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，这些疾病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：

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

在开始对慢性或复发性感染患者进行阿达木单抗-aaty治疗之前，应仔细考虑治疗的风险和益处。

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治疗期间及之后，密切监测患者是否出现感染的体征和症状，包括在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。

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（包括阿达木单抗产品）治疗的儿童和青少年患者中，已报告出现淋巴瘤和其他恶性肿瘤，其中一些为致命病例。在上市后监测中，还发现有患者在接受TNF抑制剂（包括阿达木单抗产品）治疗期间出现肝脾T细胞淋巴瘤（HSTCL），这是一种罕见的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，并且已导致死亡。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，且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..

目前尚不清楚HSTCL的发生是否与使用TNF阻滞剂或TNF阻滞剂联合其他免疫抑制剂有关。

HYPERSENSITIVITY

超敏反应

HEPATITIS B VIRUS REACTIVATION

乙型肝炎病毒再激活

NEUROLOGIC REACTIONS

神经系统反应

HEMATOLOGIC REACTIONS

血液反应

HEART FAILURE

心力衰竭

AUTOIMMUNITY

自身免疫性疾病

IMMUNIZATIONS

免疫接种

ADVERSE REACTIONS

不良反应

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：

For Yuflyma (adalimumab-aaty):

对于尤氟玛（阿达利姆单抗-aaty）：

Please click for Full U.S. Prescribing Information.

请单击以获取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；如需完整信息，请参阅各个国家的产品标签。

About Celltrion

关于Celltrion

, Inc.

公司

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar.

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

Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines.

我们的全球医药产品组合涵盖多个治疗领域，包括免疫学、肿瘤学、血液学、眼科和内分泌学。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，提供优质药品。

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

有关更多信息，请访问我们的网站 www.celltrion.com/en-us，并通过我们的社交媒体保持更新：LinkedIn、Instagram、X 和 Facebook。

About Celltrion USA

关于Celltrion美国

Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), Yuflyma®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb).

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

Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn..

Celltrion美国公司将继续利用Celltrion在生物技术方面的独特传承、供应链卓越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，并通过我们的社交媒体保持更新：LinkedIn。

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，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”、“计划”、“旨在”、“将推出”、“正在准备”、“一旦获得”、“可能”、“旨在”、“或许”、“一旦确定”、“将”、“努力实现”、“预计”、“变得可用”、“有潜力”、“预期”等词语或这些词语的否定形式、类似变体或可比术语来识别。

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的前瞻性陈述。这些陈述基于Celltrion公司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..

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

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements..

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

Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

Celltrion股份有限公司及其子公司在情况发生变化或管理层的估计或意见有所更改时，不承担更新前瞻性陈述的义务，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® is a registered trademark of Celltrion, Inc., used under license.

尤弗力玛®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、疗效与安全性，与维持组（参照阿达木单抗）的比较：III 期可互换性研究第 27 周结果。

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

[EADV 2024，海报编号 P0931]。可用链接：。

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

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。可用资源：

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

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

Source: Celltrion, Inc.

来源：Celltrion, Inc.

Yuflyma (adalimumab-aaty) FDA Approval History

Yuflyma（阿达利姆单抗-aaty）FDA批准历史

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