The US Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for FYB206 for review. To the best of the companies' knowledge, this is the first publicly announced acceptance by the USFDA of a filing for a proposed biosimilar to Keytruda

美国食品药品监督管理局（USFDA）已受理FYB206的生物制品许可申请（BLA）并进行审评。据两家公司所知，这是USFDA首次公开宣布受理针对Keytruda拟议生物类似药的申请。

®

®

.

。

FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the USFDA in early 2025.

FYB206 的开发未进行对比性 III 期疗效试验，而是遵循于 2025 年初与美国食品药品监督管理局（USFDA）商定的开发路径。

Zydus holds exclusive commercialization rights for the United States and Canada and brings extensive commercial experience in the North American market for this product.

Zydus 拥有在美国和加拿大的独家商业化权利，并为此产品在北美市场带来了丰富的商业化经验。

AHMEDABAD, India and PLANEGG-MARTINSRIED, Germany

印度艾哈迈达巴德和德国普拉内格-马丁斯里德

,

，

Oct. 13, 2026

2026年10月13日

/PRNewswire/ -- Zydus Lifesciences Limited (Zydus), an innovation-led global life-sciences company, and Formycon AG (Formycon), an independent developer of biosimilars, today jointly announced that the US Food and Drug Administration (USFDA) has accepted for review the Biologics License Application ('BLA') for FYB206, a proposed biosimilar to Keytruda.

/PRNewswire/ -- 以创新为导向的全球生命科学公司 Zydus Lifesciences Limited（Zydus）与独立生物类似药开发商 Formycon AG（Formycon）今日联合宣布，美国食品药品监督管理局（USFDA）已受理 FYB206（一种拟议的 Keytruda 生物类似药）的生物制品许可申请（BLA）并进行审评。

®1

®1

(pembrolizumab). To the best of the companies' knowledge, this is the first publicly announced acceptance by the USFDA of an application for a Keytruda

（帕博利珠单抗）。据公司所知，这是美国食品药品监督管理局（USFDA）首次公开宣布接受关于Keytruda的申请。

®

注册商标

biosimilar. The BLA was submitted in the third quarter of 2026. Under the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review within twelve months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. Based on this timeline, a decision could be expected in the third quarter of 2027.

生物类似药。该生物制品许可申请（BLA）于2026年第三季度提交。根据《生物类似药用户费修正案》（BsUFA），美国食品药品监督管理局（USFDA）旨在在提交后的12个月内完成审评，其中包括最多60天的立案审评和10个月的实质性审评。基于这一时间表，预计将在2027年第三季度作出决定。

The regulatory dossier for FYB206 has also been submitted to Health Canada..

FYB206的监管档案也已提交给加拿大卫生部。

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited said, 'Acceptance of the application marks a significant step toward expanding access to affordable pembrolizumab therapy in the U.S. and Canada. As demand for high-quality, accessible oncology treatments continues to rise, FYB206 has the potential to improve patient access and outcomes while strengthening our oncology biosimilars portfolio.

Zydus Lifesciences Limited 的董事总经理 Sharvil P. Patel 博士表示：“申请的受理标志着在扩大美国和加拿大对可负担的帕博利珠单抗治疗的可及性方面迈出了重要一步。随着对高质量、可及的肿瘤治疗药物的需求持续增长，FYB206 有望改善患者的用药可及性和治疗结局，同时增强我们的肿瘤生物类似药产品组合。”

Leveraging the biologics expertise of Formycon and our established oncology platform in North America, we remain focused on delivering meaningful value to patients.'.

凭借 Formycon 在生物制剂领域的专业知识以及我们在北美成熟的肿瘤学平台，我们继续专注于为患者提供具有实质意义的价值。

Dr. Stefan Glombitza, CEO of Formycon AG said, 'With the FDA's acceptance of the FYB206 application for review, we are among the very first companies to advance a biosimilar to the world's best-selling biologic medicine to this stage. We developed FYB206 on a path agreed with the FDA, without conducting a comparative Phase III efficacy trial.

Formycon AG 首席执行官 Stefan Glombitza 博士表示：“随着美国食品药品监督管理局（FDA）受理 FYB206 的审评申请，我们成为首批将全球最畅销生物药的商业化生物类似药推进至这一阶段的企业之一。我们按照与 FDA 商定的路径开发 FYB206，未开展 III 期临床疗效对比试验。”

This enabled us to accelerate the program and substantially reduce development investment while maintaining the rigorous scientific standards required for biosimilar approval. With Zydus, we have a partner with strong commercial capabilities and a clear oncology strategy in the US and Canada. Together, we aim to make this important cancer therapy accessible to more patients.'.

这使我们能够加速项目进程，在保持生物类似药审批所需的严格科学标准的同时，大幅减少研发投入。与Zydus合作，我们拥有了一位在美国和加拿大具备强大商业化能力并拥有清晰肿瘤学战略的合作伙伴。我们携手致力于让更多患者能够获得这一重要的癌症疗法。

Pembrolizumab is an immune checkpoint inhibitor that binds to and blocks the PD-1 receptor and is used to treat numerous types of cancer. In 2025, worldwide sales of Keytruda

帕博利珠单抗是一种免疫检查点抑制剂，通过结合并阻断PD-1受体发挥作用，用于治疗多种类型的癌症。2025年，Keytruda的全球销售额

®

®

, including the subcutaneous formulation Keytruda Qlex

，包括皮下注射制剂Keytruda Qlex

™

商标

, reached USD 31.7 billion.

，达到317亿美元。

2

2

In the first half of 2026, combined sales of Keytruda

2026年上半年，Keytruda的合并销售额

®

®

and Keytruda Qlex

以及 Keytruda Qlex

™

商标

totaled USD 16.40 billion.

总计164.0亿美元。

3

3

Keytruda

可瑞达

®

®

therefore remains the world's best-selling biologic medicine. In February 2025, Formycon agreed with the USFDA that FYB206 does not require a comparative Phase III efficacy trial.

因此，它仍然是全球最畅销的生物制剂药物。2025年2月，Formycon与美国食品药品监督管理局（USFDA）达成一致，认为FYB206无需进行对比性III期疗效试验。

In December 2025, Formycon and Zydus had entered into an exclusive licensing and supply agreement for FYB206 in the United States and Canada. Formycon is responsible for completing development, preparing and filing the regulatory dossiers, and supplying the product. With the USFDA's acceptance of the BLA for review, Formycon has reached a regulatory milestone under the agreement that entitles it to a milestone payment from Zydus.

2025年12月，Formycon与Zydus就FYB206在美国和加拿大的独家许可和供应协议达成一致。Formycon负责完成开发、准备并提交监管文件，以及供应产品。随着美国食品药品监督管理局（USFDA）受理生物制品许可申请（BLA）并进行审查，Formycon已达到协议中规定的监管里程碑，有权从Zydus获得相应的里程碑付款。

Zydus will commercialize FYB206 in both markets, subject to regulatory approval and resolution of any intellectual property issues. Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners..

在获得监管批准并解决任何知识产权问题的前提下，Zydus 将在两个市场商业化 FYB206。Formycon 拥有 FYB206 的全球权利，并将参与其商业化合作伙伴的毛利润分成。

Keytruda

可瑞达

®

®

is a registered trademark and Keytruda Qlex™ is a trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ/USA.

是注册商标，Keytruda Qlex™ 是默沙东有限责任公司（Merck Sharp & Dohme LLC）的商标，该公司为默克公司（Merck & Co., Inc.）的子公司，位于美国新泽西州拉威。

Merck & Co., Inc.: Annual Report on Form 10-K for the fiscal year 2025.

默克公司：2025财年10-K表格年度报告。

Merck & Co., Inc.: Second-Quarter 2026 Financial Results, August 4, 2026:

默克公司：2026年第二季度财务业绩，2026年8月4日：

https://www.merck.com/news/merck-highlights-key-regulatory-and-clinical-milestones-across-broad-diverse-pipeline/

https://www.merck.com/news/merck-highlights-key-regulatory-and-clinical-milestones-across-broad-diverse-pipeline/

About Zydus Lifesciences Limited:

关于Zydus Lifesciences有限公司：

Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. The group employs 30,000 people worldwide, including 1,500 scientists engaged in research and development.

Zydus Lifesciences Limited 是一家以创新为驱动的生命科学公司，在制药和消费者健康领域处于领先地位，并拥有新兴的医疗科技业务板块，业务遍布美国、印度及其他国际市场。该集团在全球拥有30,000名员工，其中包括1,500名从事研发工作的科学家。

Zydus is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that improve lives. Further information is available at .

Zydus 致力于通过改善生活的优质医疗健康解决方案，释放生命科学领域的新潜能。更多信息请访问 。

www.zyduslife.com

www.zyduslife.com

.

。

About Formycon:

关于 Formycon：

Formycon AG is a listed, independent developer of biosimilars based in Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval.

Formycon AG 是一家上市的独立生物类似药开发商，总部位于德国慕尼黑附近的马丁斯列德，这里是欧洲领先的生命科学中心之一。公司来自27个国家的200名员工覆盖了整个开发链条，从实验室分析到生产、临床试验，直至申报审批文件。

Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people..

Formycon 的三款生物类似药已在眼科和免疫学领域获得批准，并通过商业化合作伙伴在全球范围内销售。另有四款候选产品正在开发中，其中包括针对全球两款最畅销生物药的生物类似药。凭借其产品，Formycon 使更多患者能够负担得起高效疗法。

Formycon AG is listed in the Prime Standard of the (Frankfurt Stock Exchange: FYB) (ISIN: DE000A1EWVY8) (WKN: A1EWVY). Further information can be found at:

Formycon AG 在法兰克福证券交易所的 Prime Standard 板块上市（股票代码：FYB）（国际证券识别码：DE000A1EWVY8）（德国证券识别码：A1EWVY）。更多信息请访问：

www.formycon.com

www.formycon.com

About Biosimilars:

关于生物类似药：

Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the U.S.

生物类似药是生物制剂的后续产品。它们并非仿制品；每一种生物类似药都是从零开始研发，并必须向卫生监管机构证明，其在安全性和有效性方面与参照药品不存在具有临床意义的差异。根据IQVIA研究所的数据，美国将有118种销售额达2320亿美元的药物失去专利独占权。

alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible..

到2034年，仅有12种生物类似药正在研发中。在欧洲，生物类似药已节省750亿欧元，并使超过70亿天的治疗成为可能。

Disclaimer:

免责声明：

FYB206 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

FYB206 是一种研究性产品，尚未在任何国家获得监管批准。其生物相似性尚未得到监管机构的确立，亦未作此声称。

Certain statements contained in this release may constitute 'forward-looking statements' that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words 'may,' 'likely,' 'will,' 'should,' 'plan,' 'expect,' 'anticipate,' 'estimate,' 'believe,' 'intend,' 'project,' or 'aim,' or the negative of these words or other variations of these words or comparable terminology.

本新闻稿中包含的某些陈述可能构成“前瞻性陈述”，涉及多种风险和不确定性。前瞻性陈述通常可以通过使用“可能”、“大概”、“将”、“应当”、“计划”、“预期”、“预计”、“估计”、“相信”、“打算”、“规划”或“旨在”等词语，或这些词语的否定形式、其他变体或类似术语来识别。

Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change..

前瞻性陈述基于假设、预测、估计、推测、意见或计划，这些内容本质上会受到重大风险、不确定性以及可能变化的偶然因素的影响。

Zydus and Formycon do not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements.

Zydus 和 Formycon 并不且不会就任何前瞻性陈述得以实现或被证实为准确提供任何保证。实际未来的业务、财务状况、经营成果及前景可能与前瞻性陈述中预测或预期的情况存在重大差异。

Subject to applicable legal requirements, neither Zydus, Formycon nor any other person intends to update, review or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation..

在遵守适用法律要求的前提下，Zydus、Formycon 及任何其他人士均无意更新、审阅或修订本新闻稿中的任何前瞻性陈述，以反映实际事件或发展，无论是由于新信息的出现、未来发生的新进展或其他原因，且不承担任何此类义务。

SOURCE Zydus Lifesciences

来源：Zydus Lifesciences

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