Sandoz has announced the launch of its Pyzchiva® autoinjector in Europe, marking the first commercially available autoinjector in the region for a ustekinumab biosimilar.

山德士宣布在欧洲推出其Pyzchiva®自动注射器，这是该地区首个商业可用的乌司奴单抗生物类似药自动注射器。

Pyzchiva® is a biosimilar of ustekinumab, with similar efficacy and safety compared to the reference medicine Stelara®. It targets interleukin-12 and interleukin-23 and is indicated for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease, and paediatric plaque psoriasis in eligible patients..

Pyzchiva® 是乌司奴单抗的生物类似药，与参考药物 Stelara® 具有相似的疗效和安全性。它针对白细胞介素-12 和白细胞介素-23，适用于治疗符合条件的成年斑块状银屑病、银屑病关节炎、克罗恩病以及儿童斑块状银屑病患者。

The autoinjector is based on the Molly® platform from SHL Medical AG and is available in two strengths: 90 mg in 1 mL and 45 mg in 0.5 mL. Pyzchiva® is also offered in pre-filled syringes and as a concentrate in vials for infusion.

自动注射器基于 SHL Medical AG 的 Molly® 平台，提供两种规格：1 mL 中含 90 mg 和 0.5 mL 中含 45 mg。Pyzchiva® 还提供预填充注射器形式以及用于输注的小瓶装浓缩液。

Developed and registered by Samsung Bioepis, Pyzchiva® is approved for the treatment of several chronic inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and paediatric plaque psoriasis in patients aged six years and older who weigh over 60 kg.

由三星生物制药公司开发并注册的Pyzchiva®已获批用于治疗多种慢性炎症性疾病，包括斑块状银屑病、银屑病关节炎、克罗恩病以及6岁及以上且体重超过60公斤的儿童斑块状银屑病患者。

The newly introduced autoinjector is designed to support easier self-administration, offering features such as automatic dosing, reduced injection discomfort, compact design, and flexible storage. These benefits aim to improve patient experience and encourage better adherence to prescribed treatment plans..

新推出的一款自动注射器旨在更方便病人自行注射，具有自动给药、减轻注射疼痛感、设计紧凑以及储存灵活的特点。这些优点有利于改善病人的使用感受，更好地遵守处方治疗计划。

Psoriasis affects an estimated 6.4 million people in Europe, making the region the most impacted globally. Inflammatory bowel diseases like Crohn’s disease are also widespread, with around 2.5 to 3 million people affected. Non-adherence to treatment can lead to worsening symptoms, more frequent disease flares, and increased healthcare costs due to hospitalisations and additional interventions..

据估计，欧洲有640万人受银屑病影响，是全球受影响最严重的地区。像克罗恩病这样的炎症性肠病也十分普遍，约有250万到300万人受到影响。不坚持治疗可能导致症状加重、疾病发作更频繁，并因住院和额外干预而增加医疗成本。

Pyzchiva® plays a central role in Sandoz’s biosimilar strategy and is now available in 23 European markets, beginning with Spain and expanding further across the region. The product contributes to the company’s goal of improving access to treatment for patients with chronic inflammatory diseases.

Pyzchiva® 在山德士的生物仿制药战略中扮演着核心角色，现已在欧洲的 23 个市场上市，首先从西班牙开始，并进一步扩展到整个地区。该产品有助于公司实现改善慢性炎症疾病患者治疗可及性的目标。

Under a development and commercialisation agreement signed in 2023, Sandoz has exclusive rights to market Pyzchiva® in Europe, the UK, the US, Switzerland, and Brazil. Samsung Bioepis retains responsibility for development, registration, manufacturing, intellectual property, and supply.

根据2023年签署的开发和商业化协议，山德士拥有在欧洲、英国、美国、瑞士和巴西市场独家销售Pyzchiva®的权利。三星Bioepis保留对开发、注册、制造、知识产权和供应的责任。