FDA批准Merilog：这对糖尿病生物仿制药市场意味着什么:-动脉网

FDA Approves Merilog: What It Means for the Diabetes Biosimilar Market Related posts:

GeneOnline 等信源发布 2025-02-19 14:12

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by Bernice Lottering

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Merilog is the FDA's first approved rapid-acting insulin biosimilar and the third biosimilar insulin overall. Image: Shutterstock

Merilog 是 FDA 批准的首个速效胰岛素生物类似药，也是第三种获得批准的生物类似胰岛素。图片来源：Shutterstock

he U.S. Food and Drug Administration (FDA) has

美国食品药品监督管理局 (FDA) 已经

approved

已批准

Merilog (insulin aspart-szjj), a biosimilar to NovoLog (insulin aspart), marking a significant expansion in diabetes treatment options. Developed by Meitheal Pharmaceuticals and

Merilog（门冬胰岛素-szjj），是NovoLog（门冬胰岛素）的生物类似药，标志着糖尿病治疗选择的重大扩展。由Meitheal Pharmaceuticals开发，

Tonghua Dongbao Pharmaceutical

通化东宝药业

, Merilog aims to enhance insulin accessibility and affordability for millions of Americans living with diabetes.

，Merilog 旨在提高数百万美国糖尿病患者对胰岛素的可及性和可负担性。

FDA Expands Insulin Options with Merilog Approval

FDA通过Merilog批准扩大胰岛素选择范围

This approval falls under the Biologics Price Competition and Innovation Act (BPCIA), which encourages competition by allowing biosimilars to enter the market. Biosimilars offer clinically equivalent alternatives to brand-name biologics but at lower costs.

该批准属于《生物制品价格竞争与创新法案》（BPCIA），该法案通过允许生物类似药进入市场来鼓励竞争。生物类似药提供与品牌生物制品临床等效的替代品，但成本更低。

The FDA approval was based on the 6-month, phase 3 GEMELLI 1 study (

FDA 的批准是基于为期 6 个月的 3 期 GEMELLI 1 研究 (

NCT03211858

), which evaluated Merilog (SAR341402) versus originator insulin aspart in 597 patients with type 1 or type 2 diabetes using multiple daily injections with insulin glargine. At week 26, Merilog demonstrated noninferior HbA1c reduction (–0.38% vs. –0.30%), with comparable fasting plasma glucose, postprandial glucose, insulin dosages, immunogenicity, and hypoglycemia rates.

），该研究在使用甘精胰岛素进行多次每日注射的597名1型或2型糖尿病患者中，评估了Merilog（SAR341402）与原始门冬胰岛素的疗效。在第26周时，Merilog显示出非劣效的HbA1c降低效果（–0.38% vs. –0.30%），同时空腹血糖、餐后血糖、胰岛素剂量、免疫原性和低血糖发生率均相当。

The biosimilar provided effective glycemic control with a similar safety profile to the reference product. .

生物类似物提供了与参照产品相似的有效血糖控制和安全性。

According to the American Diabetes Association,

根据美国糖尿病协会，

38.4 million Americans—11.6% of the population—had diabetes

3840万美国人——占人口的11.6%——患有糖尿病

in 2021. This includes 2 million people with type 1 diabetes, among them approximately 304,000 children and adolescents. Hence, access to affordable insulin remains a public health priority, bordering on a health emergency.

在 2021 年。这包括 200 万名 1 型糖尿病患者，其中约有 304,000 名儿童和青少年。因此，获得负担得起的胰岛素仍然是一个公共卫生优先事项，几乎等同于健康紧急情况。

Merilog’s approval

梅里洛格的批准

aligns with ongoing efforts to lower insulin prices. Since 2023, major insulin producers, including

与降低胰岛素价格的持续努力保持一致。自2023年以来，包括主要的胰岛素生产商

Novo Nordisk, Eli Lilly

诺和诺德，礼来公司

, and

，以及

Sanofi

赛诺菲

, have cut insulin costs due to policy changes and pressure from lawmakers. Now, Merilog’s entry strengthens competition and could further drive down prices for patients reliant on rapid-acting insulin.

，由于政策变化和立法者的压力，已经降低了胰岛素的成本。如今，Merilog的加入增强了竞争，可能会进一步降低依赖速效胰岛素的患者的价格。

A Look at the Diabetes Landscape

糖尿病领域概览

The World Health Organization (WHO)

世界卫生组织 (WHO)

reports

报告

that global diabetes cases increased from 200 million in 1990 to 830 million in 2022. Low- and middle-income countries have experienced a faster rise in diabetes cases than high-income nations. In 2022, an estimated 14% of adults had diabetes, with 59% not receiving medication for treatment. Complications from diabetes caused 1.6 million deaths in 2021, with 47% occurring in people under 70..

全球糖尿病病例从1990年的2亿增加到2022年的8.3亿。低收入和中等收入国家的糖尿病病例增长速度高于高收入国家。2022年，估计有14%的成年人患有糖尿病，其中59%未接受药物治疗。2021年，糖尿病并发症导致160万人死亡，其中47%发生在70岁以下的人群中。

The International Diabetes Federation (IDF)

国际糖尿病联合会 (IDF)

projects

项目

that 783 million adults will have diabetes by 2045, a 46% increase from 2021. Urbanization, aging populations, reduced physical activity, and rising obesity rates contribute to this trend. Africa faces the highest increase, with cases expected to grow by 134%.

到2045年，将有7.83亿成年人患有糖尿病，比2021年增加46%。城市化、人口老龄化、体力活动减少和肥胖率上升是这一趋势的推动因素。非洲面临最高的增长，预计病例将增加134%。

Type 2 diabetes accounts for

2型糖尿病占

90%

of all cases worldwide. Once common in older adults, it is now rising in children and young adults. Poor diets and increasing obesity rates drive this shift. In 2022,

全球所有病例中。曾经在老年人中很常见，现在在儿童和年轻人中呈上升趋势。不良的饮食和不断上升的肥胖率推动了这一转变。2022年，

approximately

大约

8.75 million people were diagnosed with Type 1 diabetes.

875万人被诊断出患有1型糖尿病。

Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the FDA’s Center for Drug Evaluation and Research, emphasized the importance of biosimilar insulin options in a news release,

美国食品药品监督管理局药物评估与研究中心治疗性生物制品和生物类似药办公室主任莎拉·伊姆医学博士在新闻稿中强调了生物类似胰岛素选择的重要性。

stating

声明

, “For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications.”

“对于数百万依赖每日胰岛素注射治疗糖尿病的患者来说，拥有一个速效胰岛素注射的生物类似药选项确实可以带来改变，因为生物类似药有潜力增加这些救命药物的可及性。”

The Growing Biosimilar Insulin Market

不断增长的生物仿制胰岛素市场

Merilog joins a growing list of biosimilar insulins, providing additional choices for diabetes patients and healthcare providers. The biosimilar insulin market already includes Rezvoglar (insulin glargine-aglr) and Basaglar (insulin glargine),

Merilog 加入了不断增长的生物类似胰岛素行列，为糖尿病患者和医疗保健提供者提供了更多选择。生物类似胰岛素市场已经包括 Rezvoglar（甘精胰岛素-aglr）和 Basaglar（甘精胰岛素）。

both biosimilars of Lantus

两种Lantus的生物类似药

, manufactured by Eli Lilly. Semglee (insulin glargine-yfgn), developed by Biocon and Viatris, remains the

，由礼来公司生产。Semglee（甘精胰岛素-yfgn），由百康和维特里斯开发，仍然是

first and only interchangeable

首个且唯一的可互换

biosimilar insulin, meaning pharmacists can substitute it for Lantus without physician approval.

生物仿制胰岛素，意味着药剂师可以在未经医生批准的情况下用它替代Lantus。

While biosimilars promise affordability, adoption remains slow due to multiple challenges. Unlike generic drugs, biosimilars require extensive testing to demonstrate similarity to reference biologics, increasing development costs. Additionally, pricing negotiations with insurers and pharmacy benefit managers influence market penetration.

虽然生物仿制药承诺了可负担性，但由于多重挑战，其采用仍然缓慢。与仿制药不同，生物仿制药需要进行广泛的测试以证明其与参比生物药的相似性，这增加了开发成本。此外，与保险公司和药品福利管理机构的价格谈判也影响了市场渗透。

Some physicians hesitate to switch patients from well-established brands due to concerns about insurance coverage and potential differences in formulation, even when biosimilars are proven to be equally effective..

一些医生由于担心保险覆盖范围和配方的潜在差异，即使生物类似药被证明同样有效，也不愿将患者从成熟的品牌转换过来。

The

FDA continues efforts to streamline biosimilar approvals

FDA继续努力简化生物仿制药的审批流程。

, aiming to accelerate competition. Market analysts

，旨在加速竞争。市场分析师

predict

预测

that an increasing number of biosimilar insulins could reshape diabetes treatment pricing over the next decade, making it more sustainable for patients and healthcare systems alike.

越来越多的生物类似物胰岛素可能会在未来十年重塑糖尿病治疗的定价，使其对患者和医疗系统而言都更加可持续。

Market Trends and Competitive Landscape

市场趋势与竞争格局

The biosimilar insulin market is expanding rapidly as patent protections on biologic insulins expire, opening the door for new competition. Sanofi, traditionally known for producing Lantus, has introduced Insulin Aspart Sanofi, a biosimilar to Novo Nordisk’s NovoLog. Eli Lilly continues to position itself as a leader in biosimilar insulin production, leveraging its manufacturing capabilities to reduce costs and capture market share.

生物类似物胰岛素市场正在迅速扩张，因为生物胰岛素的专利保护到期，为新的竞争打开了大门。以生产Lantus而闻名的赛诺菲推出了赛诺菲胰岛素Aspart，这是诺和诺德NovoLog的生物类似物。礼来公司继续将自己定位为生物类似物胰岛素生产的领导者，利用其生产能力降低成本并获取市场份额。

New entrants, including .

新进入者，包括。

Gan & Lee Pharmaceuticals

甘李药业

, are expanding biosimilar offerings, particularly in emerging markets.

，正在扩大生物仿制药的供应，尤其是在新兴市场。

The growing competition is driving aggressive pricing strategies among manufacturers. Biosimilar developers are working to establish agreements with insurance providers and government programs to facilitate greater adoption. Some European countries have already

日益激烈的竞争正在推动制造商采取激进的定价策略。生物仿制药开发商正努力与保险公司和政府项目达成协议，以促进更广泛的采用。一些欧洲国家已经

implemented policies favoring biosimilars

实施了支持生物仿制药的政策

, incentivizing their use in place of costlier reference biologics. The U.S. market is slowly following suit, though regulatory hurdles and provider hesitancy remain significant barriers.

，激励人们使用它们来替代更昂贵的参照生物制品。美国市场正在缓慢跟进，尽管监管障碍和供应商犹豫仍然是重要的阻碍。

Despite these challenges, biosimilar insulins continue gaining traction. The Biden administration’s

尽管存在这些挑战，生物仿制胰岛素仍在不断取得进展。拜登政府的

Inflation Reduction Act

《通货膨胀削减法案》

capped insulin prices at $35 per month for Medicare beneficiaries, but many uninsured and privately insured patients still face high costs. Expanding biosimilar adoption could create broader price reductions across all patient groups, benefiting both individuals and healthcare systems.

将医疗保险受益人的胰岛素价格上限定为每月35美元，但许多无保险和私人保险的患者仍面临高昂的费用。推动生物仿制药的普及可能会为所有患者群体带来更广泛的价格下降，使个人和医疗系统都从中受益。

Combining Forces: Biosimilars and Advanced Drug Delivery for Next-Level Therapies

结合力量：生物仿制药与先进药物递送技术助力下一代疗法

The diabetes treatment landscape is evolving beyond traditional insulin therapies, with biosimilars playing an increasingly important role in innovation. Researchers are developing

糖尿病治疗领域正在超越传统的胰岛素疗法，生物仿制药在创新中发挥着越来越重要的作用。研究人员正在开发

next-generation biosimilars

下一代生物仿制药

with improved properties, such as ultra-rapid-acting insulins and long-acting insulin analogs. These advancements aim to enhance glycemic control, reduce injection frequency, and improve patient adherence.

具有改进特性的胰岛素，例如超速效胰岛素和长效胰岛素类似物。这些进步旨在增强血糖控制，减少注射频率，并提高患者的依从性。

In addition, biosimilar developers are exploring combination therapies that integrate biosimilars with advanced drug delivery technologies. Pairing

此外，生物仿制药开发商正在探索将生物仿制药与先进的药物递送技术相结合的组合疗法。配对

insulin biosimilars

胰岛素生物类似药

with continuous glucose monitoring (CGM) systems and smart insulin pens enhances treatment precision by providing real-time glucose data and personalized dosing recommendations. Such innovations could revolutionize diabetes care by optimizing outcomes and simplifying disease management.

通过连续血糖监测（CGM）系统和智能胰岛素笔，提供实时血糖数据和个性化剂量建议，从而提高治疗的精确性。此类创新可以通过优化治疗效果和简化疾病管理，彻底改变糖尿病的护理方式。

Researchers are also investigating

研究人员也在调查

alternative insulin delivery methods

替代胰岛素输送方法

, including oral and inhalable biosimilars. While challenges such as bioavailability and stability remain, ongoing clinical trials show promising potential. If successful, these new formulations could reduce reliance on injections and improve patient compliance. Merilog is administered subcutaneously in the abdomen, buttocks, thighs, or upper arms within 5 to 10 minutes before meals, similar to Novolog.

，包括口服和吸入式生物类似药。尽管生物利用度和稳定性等挑战依然存在，但正在进行的临床试验显示出良好的潜力。如果成功，这些新配方可以减少对注射的依赖并提高患者的依从性。Merilog 在餐前 5 到 10 分钟内通过腹部、臀部、大腿或上臂皮下注射给药，类似于 Novolog。

Dosage is individualized based on patient needs..

剂量根据患者需求个体化。

Looking ahead, the combination of increasing biosimilar availability, policy support, and continuous research efforts will shape the future of diabetes care. Biosimilars will not only help lower treatment costs but also contribute to advancements in drug efficacy and delivery, ultimately improving quality of life for millions of people with diabetes worldwide..

展望未来，生物类似药供应增加、政策支持和持续的研究努力将共同塑造糖尿病护理的未来。生物类似药不仅有助于降低治疗成本，还将促进药物疗效和递送方式的进步，最终改善全球数百万糖尿病患者的生活质量。

Expanding Biosimilar Adoption: A Key to Lower Prices for All Patients

扩大生物仿制药的采用：降低所有患者价格的关键

Despite increasing biosimilar approvals, patient adoption faces hurdles. Many healthcare providers hesitate to switch patients from established brands due to concerns about insurance coverage and physician preference. Additionally, pharmacy chains often lack incentives to stock biosimilars over branded insulins..

尽管生物仿制药的获批数量不断增加，但患者接受度仍面临障碍。许多医疗保健提供者由于担心保险覆盖范围和医生偏好，而不愿将患者从知名品牌转换到生物仿制药。此外，连锁药店往往缺乏动力去储存生物仿制药而非品牌胰岛素。

Regulatory policies continue evolving to address these barriers. The Biden administration’s Inflation Reduction Act capped insulin prices at $35 per month for Medicare beneficiaries, but many uninsured and privately insured patients still struggle with high costs. Industry stakeholders argue that expanding biosimilar adoption could drive broader price reductions across all patient groups..

监管政策持续演变以应对这些障碍。拜登政府的《通胀削减法案》将医疗保险受益人的胰岛素价格上限设定为每月35美元，但许多无保险和私人保险患者仍面临高昂费用。行业利益相关者认为，扩大生物仿制药的采用可能推动各患者群体更广泛的价格下降。

Looking ahead, analysts expect further biosimilar developments. Companies like

展望未来，分析师预计生物仿制药领域将有进一步的发展。像

Biocon, Samsung Bioepis

百康，三星生物 epis

, and Gan & Lee Pharmaceuticals are advancing new biosimilar insulin candidates. As more products enter the market, competition will likely intensify, pressuring brand-name manufacturers to maintain competitive pricing.

，甘李药业也在推进新的生物类似物胰岛素候选产品。随着更多产品进入市场，竞争可能会加剧，迫使品牌制造商保持有竞争力的定价。

Merilog’s approval represents progress toward a more competitive insulin market. While challenges remain, continued biosimilar development and policy support could transform diabetes care affordability, ensuring millions of Americans have better access to life-saving treatments.

Merilog的获批代表着向更具竞争力的胰岛素市场迈出了进步。尽管挑战依然存在，但持续的生物类似药开发和政策支持可能会改变糖尿病治疗的可负担性，确保数百万美国人更好地获得挽救生命的治疗。