Sandoz has introduced Afqlir® (aflibercept) in Europe, expanding access to treatment for adults with various retinal diseases. The product, supplied as a 2 mg vial kit and a pre-filled syringe for intravitreal injection, received European Commission approval in November 2024. Afqlir® is authorised for the same uses as the reference medicine Eylea®, including the treatment of several retinal conditions that can lead to vision loss.

山德士在欧洲推出了Afqlir®（阿柏西普），扩大了成人各种视网膜疾病的治疗可及性。该产品以2毫克小瓶套装和预填充注射器形式供应，用于玻璃体内注射，并于2024年11月获得欧盟委员会批准。Afqlir®被授权的用途与参考药物Eylea®相同，包括治疗可能导致视力丧失的多种视网膜疾病。

Clinical studies have shown that Afqlir® matches the reference product in terms of efficacy, safety and pharmacokinetics..

临床研究表明，Afqlir® 在有效性、安全性和药代动力学方面与参照产品相匹配。

Aflibercept is widely regarded as a key treatment for neovascular retinal diseases. Conditions such as age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular oedema are among the main causes of vision impairment worldwide, with the number of affected patients continuing to grow..

阿柏西普被广泛认为是治疗新生血管性视网膜疾病的关键药物。年龄相关性黄斑变性（AMD）、视网膜静脉阻塞和糖尿病性黄斑水肿等疾病是全球视力损害的主要原因之一，受影响的患者数量持续增长。

Neovascular age-related macular degeneration (nAMD), a form of AMD, leads to vision loss in the central field of vision and is a major cause of severe visual impairment in people over 65. Although nAMD accounts for a smaller proportion of total AMD cases, it is responsible for the vast majority of serious vision loss linked to the disease.

新生血管性年龄相关性黄斑变性（nAMD）是年龄相关性黄斑变性的一种形式，会导致中央视野的视力丧失，是65岁以上人群严重视力障碍的主要原因之一。尽管nAMD在所有AMD病例中占比相对较小，但它却是与该疾病相关的绝大多数严重视力损失的罪魁祸首。

Across major markets including France, Germany, Italy, Spain, the UK, the US and Japan, an estimated four million people are affected by nAMD. Of these, 2.8 million have been diagnosed, but only about two million receive treatment..

在包括法国、德国、意大利、西班牙、英国、美国和日本在内的主要市场，大约有四百万人受到nAMD的影响。其中，280万人已被诊断出患病，但只有约两百万人接受治疗。

Afqlir® will be introduced gradually across Europe, starting with the UK, followed by Germany and France, with wider availability expected in 2026.

Afqlir®将逐步在欧洲推出，首先在英国上市，随后是德国和法国，预计到2026年会有更广泛的供应。

The launch strengthens the Sandoz biosimilar portfolio and forms part of the company’s broader growth strategy. It follows recent introductions of biosimilars such as Tyruko® (natalizumab), Wyost® (denosumab) and Jubbonti® (denosumab) in the United States.

此次上市增强了山德士的生物类似药产品组合，并成为该公司更广泛增长战略的一部分。此前，山德士近期在美国推出了诸如Tyruko®（那他珠单抗）、Wyost®（地诺单抗）和Jubbonti®（地诺单抗）等生物类似药。

Sandoz aims to support access to essential biologic treatments through a broad and expanding biosimilar portfolio. The company currently offers 13 biosimilars worldwide, with an additional 27 in development. Afqlir® also reinforces the company’s long-standing leadership in biosimilars and enhances its position in the global anti-VEGF ophthalmology market, valued at around USD 15 billion..

山德士旨在通过广泛且不断扩展的生物类似药组合来支持获取基本的生物疗法。该公司目前在全球提供13种生物类似药，并有另外27种正在开发中。Afqlir®也加强了该公司在生物类似药领域的长期领导地位，并增强其在全球价值约150亿美元的抗VEGF眼科市场中的地位。

In September 2025, Sandoz reached an agreement with Regeneron Pharmaceuticals, Inc. to resolve all patent-related disputes concerning its FDA-approved aflibercept biosimilar. This agreement clears the way for the planned US launch of Enzeevu™ (aflibercept-abzv) by the end of 2026.

2025年9月，山德士与再生元制药公司达成协议，解决了与其FDA批准的阿柏西普生物类似药相关的所有专利纠纷。该协议为计划于2026年底在美国推出Enzeevu™（阿柏西普-abzv）扫清了障碍。

Source: sandoz.com

来源：sandoz.com