Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable* biosimilar to NovoLog® (Insulin Aspart).

生物康生物制药有限公司（BBL），一家完全整合的全球生物仿制药公司，也是生物康有限公司（BSE代码：532523，NSE：BIOCON）的子公司，今天宣布美国食品药品监督管理局（FDA）已批准Kirsty™（门冬胰岛素-xjhz），100单位/毫升，作为与诺和锐®（门冬胰岛素）首个且唯一的可互换*生物仿制药。

KIRSTY is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. KIRSTY will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use..

KIRSTY是一种速效的人胰岛素类似物，用于改善成人和糖尿病患儿的血糖控制。KIRSTY将作为单人使用的预填充笔供皮下使用，并提供多剂量瓶装供皮下和静脉使用。

The FDA approval of KIRSTY expands Biocon Biologics’ biosimilar insulin portfolio, which also includes the first approved interchangeable biosimilar, Semglee® (Insulin Glargine-yfgn Injection). KIRSTY has been available in Europe and Canada since 2022.

美国食品药品监督管理局（FDA）批准了KIRSTY，这扩展了Biocon Biologics的生物类似胰岛素产品组合，其中还包括首个获批的可互换生物类似药Semglee®（甘精胰岛素-yfgn注射液）。KIRSTY自2022年以来已在欧洲和加拿大上市。

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: “The FDA approval of Kirsty™, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the U.S., is a significant step forward in our efforts to make insulin more accessible and affordable. It builds on the foundation we laid with Semglee®, reinforcing our commitment to scientific excellence and patient-centric innovation.

Biocon Biologics Ltd. 首席执行官兼董事总经理Shreehas Tambe表示：“Kirsty™获得FDA批准，这是美国首个也是唯一一个可互换的速效胰岛素Aspart生物类似药，是我们努力使胰岛素更易获得、更实惠的重要一步。它建立在我们推出Semglee®时奠定的基础上，进一步彰显了我们对科学卓越和以患者为中心的创新的承诺。”

With Kirsty™, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care.”.

“通过Kirsty™，我们正在为糖尿病患者扩展治疗选择，并推进我们成为满足糖尿病护理中未满足需求的全球领导者的雄心。”

There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter of them being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.1 Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA..

美国有 3840 万名糖尿病患者，约占总人口的 11.6%，其中近四分之一未被诊断。另有 9760 万美国人被确定为糖尿病前期患者。据 IQVIA 统计，2024 年门冬胰岛素在美国的销售额约为 19 亿美元。

Biocon Biologics is a global leader in biosimilars and insulin production and is among the top three global players for rh- Insulin and Insulin Glargine, providing over 9.2 billion doses of insulin globally with a broad portfolio comprising basal, mixed and rapid acting insulins.

Biocon Biologics 是生物仿制药和胰岛素生产的全球领导者，是全球排名前三的重组人胰岛素和甘精胰岛素生产商之一，拥有包括基础胰岛素、混合胰岛素和速效胰岛素在内的广泛产品组合，向全球供应超过 92 亿剂胰岛素。

The Company has achieved many “firsts” in the industry including the first to receive approval of biosimilar Trastuzumab in the United States, Ogivri®, as well as Fulphila™ (bPegfilgrastim), and Semglee® (bInsulin Glargine) in the United States. Globally, serving over 5.8M patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including eight in the United States and seven in Canada, with a robust portfolio of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas..

该公司在行业内取得了多项“第一”，包括在美国首个获得生物类似药曲妥珠单抗（Trastuzumab）批准的药物 Ogivri®，以及 Fulphila™（bPegfilgrastim）和 Semglee®（bInsulin Glargine）。在全球范围内，Biocon Biologics 每年为超过 580 万患者提供服务，拥有涵盖多种治疗领域的全面上市和在研生物类似药产品组合，其中包括八种在美国上市的产品和七种在加拿大上市的产品，并拥有包括胰岛素和单克隆抗体在内的 20 种生物类似药资产的强大产品组合，覆盖多个治疗领域。

* An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch.

* 一种可互换产品（IP）是基于数据证明与FDA批准的参照产品（RP）高度相似，并且两者之间没有临床意义上的差异而获得批准的生物制品；在任何特定患者中，预计其产生的临床效果与参照产品相同；如果对患者多次给药，在安全性和有效性降低方面，交替或切换使用参照产品和可互换产品的风险不高于单独使用参照产品的风险。

Interchangeability of KIRSTY has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information..

KIRSTY的互换性已在完整处方信息中描述的使用条件、剂量、剂型和给药途径方面得到证实。

About KIRSTY:

关于KIRSTY：

The approval for KIRSTY was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that KIRSTY is highly similar to NOVOLOG. The data demonstrated that there were no clinically meaningful differences between KIRSTY and NOVOLOG in terms of safety, efficacy, purity and potency. .

KIRSTY 的批准基于一份包含分析、非临床和临床数据的综合资料包，这些数据确认 KIRSTY 与 NOVOLOG 高度相似。数据显示，在安全性、有效性、纯度和效力方面，KIRSTY 与 NOVOLOG 之间没有临床上有意义的差异。

Important safety information:

重要的安全信息：

KIRSTY is contraindicated

KIRSTY 是禁忌的

Warnings and Precautions:

警告和注意事项：

Please refer to full Prescribing Information for KIRSTY (Insulin Aspart-xjhz injection) for more information.

请参阅KIRSTY（门冬胰岛素-xjhz注射液）的完整处方信息以获取更多详情。

KIRSTY™ is a trademark of Biocon Biologics Limited.

KIRSTY™ 是 Biocon Biologics Limited 的商标。

SEMGLEE® is a registered trademark of Biosimilars Newco Limited, a Biocon Biologics Company.

SEMGLEE® 是 Biocon Biologics 公司旗下 Biosimilars Newco Limited 的注册商标。

Biocon Biologics & Logo are registered trademarks of Biocon Biologics Limited.

Biocon Biologics及Logo是Biocon Biologics Limited的注册商标。

All other trademarks are the property of their respective owners.

所有其他商标均为其各自所有者的财产。

1 U.S. Department of Health & Human Services, Centers for Disease Control and Prevention. “National Diabetes Statistics Report.” Accessed: January 28, 2025. Last Reviewed: May 15, 2024. https://www.cdc.gov/diabetes/php/data-research/index.html

1 美国卫生与公众服务部，疾病控制与预防中心。《全国糖尿病统计报告》。访问日期：2025年1月28日。最后审核日期：2024年5月15日。https://www.cdc.gov/diabetes/php/data-research/index.html

About Biocon Biologics Limited:

关于百康生物制药有限公司：

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve over 5.8 million patients across 120+ countries by enabling affordable access to high quality biosimilars.

Biocon Biologics Limited是Biocon Limited的子公司，是一家独特的、完全集成的全球生物仿制药公司，致力于改变医疗保健和改变生活。它利用其“从实验室到市场”的能力，通过提供高质量且价格合理的生物仿制药，为120多个国家的超过580万名患者服务。

The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes..

公司正在利用尖端科学、创新技术平台、全球规模的制造能力和世界级的质量体系，以降低生物治疗药物的成本，同时改善医疗保健效果。

Biocon Biologics has commercialized nine biosimilars from its portfolio which are addressing the patients’ needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases.

生物康生物制品公司已经将其产品组合中的九种生物类似药商业化，这些药物正在满足美国、欧洲、澳大利亚、加拿大和日本等主要新兴市场和发达市场患者的需求。该公司在糖尿病学、肿瘤学、免疫学、眼科学、骨骼健康及其他非传染性疾病领域拥有20种生物类似药的产品管线。

The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: www.bioconbiologics.com; Follow us on  X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates.

该公司在生物仿制药行业有许多“第一”值得称道。作为其环境、社会和治理（ESG）承诺的一部分，它正在推动患者、人民和地球的健康，以实现关键的联合国可持续发展目标（SDGs）。网站：www.bioconbiologics.com；关注我们的X（前身为Twitter）：@BioconBiologics 和 LinkedIn：Biocon Biologics 以获取公司更新。

For FY24 Integrated Annual Report of Biocon Biologics click here.

要查看Biocon Biologics的24财年综合年度报告，请点击这里。

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets.

Biocon Limited于2004年公开上市（孟买证券交易所代码：532523，NSE代码：BIOCON，ISIN代码：INE376G01013），是一家创新驱动的全球生物制药公司，致力于为糖尿病、癌症和自身免疫等慢性疾病提供可负担的复杂疗法。该公司在印度及多个关键全球市场开发并商业化了新型生物制品、生物类似药和复杂的小分子原料药，同时还在美国、欧洲及关键新兴市场推出了仿制药制剂。

It also has a pipeline of promising novel assets in immunotherapy under development. .

它还在开发中的免疫治疗领域有一系列前景看好的新型资产管道。

Website: www.biocon.com; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates.

网站：www.biocon.com；关注我们的X（原推特）@bioconlimited 和领英：Biocon，获取公司更新。

Forward-Looking Statements: Biocon

前瞻性声明：百康生物科技公司

This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements.

本新闻稿可能包含基于管理层对未来发展及其对 Biocon 及其子公司/关联公司潜在影响的当前预期和信念的未来预期声明及其他前瞻性陈述。这些前瞻性陈述涉及已知或未知的风险和不确定性，可能导致实际结果、表现或事件与这些声明中明示或暗示的内容存在重大差异。

Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India.

可能导致实际结果与我们预期存在重大差异的重要因素包括：印度及海外的一般经济和商业状况、我们成功实施战略的能力、我们的研发工作、我们的增长和扩张计划以及技术变革、卢比及其他货币价值的变化、印度和国际利率的变化、适用于印度和全球生物技术及制药行业的法律法规的变化、印度和全球生物技术及制药行业竞争加剧及行业状况变化、印度政治状况的变化以及印度外汇管制法规的变化等。

Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release..

本公告中包含的任何前瞻性声明，Biocon公司、董事会成员或子公司/关联公司均不承担更新义务。

Source: biocon.com

来源：biocon.com