A Sanofi subsidiary has claimed FDA approval for the first biosimilar of Novo Nordisk's Novolog, an older formulation of the Danish pharma's blockbuster insulin analogue product insulin aspart.

赛诺菲旗下子公司声称已获得FDA批准，成为诺和诺德Novolog的第一款生物类似药，这是丹麦制药公司 blockbuster 胰岛素类似物产品胰岛素门冬的较早配方。

Sanofi-Aventis' Merilog version of the product has been cleared for the treatment of adult and paediatric patients with type 2 diabetes. It is the first

赛诺菲-安万特公司的Merilog版本产品已被批准用于治疗成年和儿童2型糖尿病患者。这是第一个

biosimilar

生物仿制药

of a rapid-acting insulin product – used to control the blood glucose spike after meals – and only the third insulin biosimilar to be approved in the US.

快速作用的胰岛素产品——用于控制餐后血糖飙升——并且是美国批准的第三种胰岛素生物类似药。

Novo Nordisk's insulin aspart franchise is a DKK 10.6 billion ($1.5 billion) business worldwide, with NovoLog (known as NovoRapid outside the US) making up the bulk (around DKK 9 billion) of global sales. The US is in turn the largest contributor with sales there of around DKK 7.5 billion last year..

诺和诺德的门冬胰岛素业务在全球范围内是一个价值106亿丹麦克朗（15亿美元）的业务，其中诺和锐（美国以外地区称为NovoRapid）占据了全球销售额的主要部分（约90亿丹麦克朗）。美国是最大的贡献者，去年在该国的销售额约为75亿丹麦克朗。

Novo Nordisk has developed a new version of the insulin analogue, called Fiasp, which added another DKK 1.6 billion to the fast-acting insulin pot last year and has patent protection to 2030.

诺和诺德开发了一种新的胰岛素类似物版本，称为Fiasp，去年为速效胰岛素市场增添了16亿丹麦克朗，并拥有到2030年的专利保护。

Peter Stein, director of the Office of New Drugs in the FDA's Centre for Drug Evaluation and Research (CDER), said the approval of the third biosimilar insulin 'highlights our continued efforts to improve the efficiency of the biosimilar approval process to help support a competitive marketplace and increase options for costly treatments, like insulin.'.

FDA药品评价与研究中心（CDER）新药办公室主任彼得·斯坦因表示，第三种生物类似胰岛素的批准“凸显了我们持续改进生物类似药审批流程效率的努力，以支持市场竞争并增加昂贵治疗选择，如胰岛素。”

Merilog has been cleared in a 3ml single-patient-use prefilled pen and a 10ml multiple-dose vial should be administered by subcutaneous injection within five to 10 minutes before the start of a meal. NovoLog is also available in pen injector formats.

Merilog 已被批准用于3毫升单人使用预填充笔和10毫升多剂量瓶，应在餐前5至10分钟内通过皮下注射给药。NovoLog 也有笔式注射器形式提供。

Before Merilog, the FDA has given the go-ahead to two biosimilars of Sanofi's basal insulin product Lantus (insulin glargine) – Viatris'

在Merilog之前，FDA已经批准了赛诺菲基础胰岛素产品Lantus（甘精胰岛素）的两种生物类似药——Viatris公司的

Semglee

Semglee

and Eli Lilly's Rezvoglar – which are used to provide a background level of insulin over the course of the day and reached the market in 2021.

和礼来公司的Rezvoglar——这些药物用于在一天中提供基础水平的胰岛素，并于2021年上市。

The biosimilars reach the US market as the US insulin space has seen seismic changes in the last few years, with a clamour of calls for

生物仿制药进入美国市场之际，美国胰岛素领域在过去几年发生了翻天覆地的变化，伴随着一片呼吁之声。

price cuts

价格下调

that have led the big producers to slash prices for some of their older products and the introduction of a mandatory $35 monthly insulin

这些因素导致大型生产商大幅降低部分老产品的价格，并引入了强制性的每月35美元胰岛素。

copay cap

共付额上限

for Medicare.

医疗保险。

While a few years ago the loss of patent protection for a big insulin brand would have been a deal for Novo Nordisk, surging sales of the GLP-1 agonist class of diabetes therapies like Ozempic (semaglutide) have reduced the impact.

虽然几年前，一个大型胰岛素品牌失去专利保护对诺和诺德来说可能是个重大事件，但像Ozempic（司美鲁肽）这类GLP-1激动剂类糖尿病疗法的销售激增，降低了这一影响。

The company is in the process of removing older insulin products from the market, in part so it can divert manufacturing capacity for newer, growth products in its GLP-1 stable.

公司正在逐步将较旧的胰岛素产品退出市场，部分原因是为了将其生产能力转向其GLP-1系列中较新且增长潜力更大的产品。

More than 38 million people in the US have been diagnosed with diabetes, and about 8.4 million Americans rely on insulin therapy.

美国有超过3800万人被诊断出患有糖尿病，约840万美国人依赖胰岛素治疗。

'

'

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,' said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at CDER..

对于数百万依赖每日注射胰岛素来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。

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MasterTux

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from

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