Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab-ttwe) in the US. From today, the medicine is commercially available to patients across the US.

山德士（Sandoz），全球仿制药和生物类似药领域的领导者，宣布在美国推出Pyzchiva®*（乌司奴单抗-ttwe）。从今天起，该药物在美国全面上市，供患者使用。

Developed by Samsung Bioepis Co., Ltd., and commercialized by Sandoz, Pyzchiva® has been approved by the US Food and Drug Administration (FDA) for the treatment of certain chronic inflammatory diseases, with the same indications as reference medicine Stelara®**[5].

由三星生物制药有限公司开发、山德士公司商业化的Pyzchiva®已获美国食品药品监督管理局（FDA）批准，用于治疗某些慢性炎症性疾病，其适应症与参考药物Stelara®相同**[5]。

Pyzchiva® is a key biosimilar value driver for Sandoz, contributing to the company’s overall growth strategy. The company ranks number one in biosimilars globally and across key markets in Europe. The commercial availability of Pyzchiva®, which builds on the US launch of Hyrimoz® in July 2023, marks an important step in the Sandoz strategic ambition to become number one in biosimilars in the US..

Pyzchiva® 是山德士的关键生物类似药价值驱动因素，有助于公司的整体增长战略。该公司在全球及欧洲主要市场中生物类似药领域排名第一。Pyzchiva® 的商业上市建立在2023年7月 Hyrimoz® 在美国上市的基础上，标志着山德士实现在美国生物类似药领域成为第一的战略目标的重要一步。

Keren Haruvi, President, Sandoz North America, said: “This is an important moment for millions of patients living with chronic autoimmune diseases.[1-4] The launch of Pyzchiva® reinforces our commitment to broaden access to treatment options for patients, while helping to build a more sustainable healthcare system in the US so that everyone can access the medicines they need, when they need them.”.

凯伦·哈鲁维，山德士北美区总裁表示：“这对于数百万患有慢性自身免疫性疾病的患者而言是一个重要的时刻。[1-4] Pyzchiva®的推出进一步印证了我们致力于为患者拓宽治疗选择的承诺，同时也助力构建一个更加可持续发展的美国医疗体系，确保每个人都能在需要时获得所需的药物。”

Pyzchiva® offers an affordable option for patients who could benefit from treatment with ustekinumab. It also provides the full suite of dosing options to meet the needs of a variety of patients and is expected to offer interchangeability in the first half of 2025. Pyzchiva® elevates the patient experience with extended stability, including the ability to be re-refrigerated, unlike the reference medicine..

Pyzchiva® 为可能受益于乌司奴单抗治疗的患者提供了一个经济实惠的选择。它还提供了全套的剂量选项，以满足不同患者的需求，并预计在2025年上半年实现互换性。Pyzchiva® 通过延长稳定性（包括可重新冷藏的能力）提升了患者的使用体验，而参考药物则不具备这一特性。

Leah M. Howard, J.D., the president and CEO of the National Psoriasis Foundation, said: “Psoriasis and psoriatic arthritis are chronic diseases that can be treated with biologics, but those medications are often not as accessible or affordable as they should be for those who could benefit most from them.

利娅·M·霍华德，法学博士，全国银屑病基金会主席兼首席执行官表示：“银屑病和银屑病关节炎是可以通过生物制剂治疗的慢性疾病，但这些药物往往不像那些最能从中受益的人所期望的那样可及或负担得起。”

Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them.”.

生物仿制药为那些以前可能负担不起这些有效治疗选择的人提供了巨大的潜力。"

Sandoz is providing comprehensive support resources for patients who are prescribed Pyzchiva®, including information about insurance coverage/benefit investigation, self-injection training, and a co-pay program for commercially insured patients.

山德士为被处方Pyzchiva®的患者提供全面的支持资源，包括有关保险覆盖/福利调查、自我注射培训以及针对商业保险患者的共付计划的信息。

This launch is in accordance with the settlement and license agreement with Johnson & Johnson for the US market, previously announced by Samsung Bioepis Co., Ltd. Sandoz entered into a commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva® in the US, Canada, the European Economic Area, Switzerland, the UK and Brazil.

此次上市是根据三星生物制药有限公司此前宣布的与强生公司针对美国市场的和解和许可协议进行的。山德士于2023年9月与三星生物制药就生物类似药乌司奴单抗达成商业化协议。根据协议条款，山德士有权在美国、加拿大、欧洲经济区、瑞士、英国和巴西商业化Pyzchiva®。

Samsung Bioepis Co., Ltd. remains responsible for development, registration, intellectual property, manufacturing and supply..

三星生物制药有限公司仍然负责开发、注册、知识产权、制造和供应。

About Pyzchiva® (ustekinumab-ttwe)

关于Pyzchiva®（乌司奴单抗-ttwe）

Ustekinumab, the active ingredient in Pyzchiva®, is a human monoclonal antibody targeting IL-12 and IL-23, which are cytokines that when overproduced can cause inflammation. This inflammation plays a role in the development of certain autoimmune conditions. Pyzchiva® works by blocking IL-12 and IL-23 proteins.[6].

Pyzchiva® 的活性成分乌司奴单抗是一种人源化单克隆抗体，靶向白细胞介素-12（IL-12）和白细胞介素-23（IL-23），这些细胞因子在过度产生时可能引发炎症。这种炎症在某些自身免疫性疾病的发病中起作用。Pyzchiva® 通过阻断 IL-12 和 IL-23 蛋白发挥作用。[6]

Pyzchiva® has been approved by the FDA to treat adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis..

Pyzchiva® 已获 FDA 批准用于治疗患有中度至重度斑块型银屑病、活动性银屑病关节炎、中度至重度活动性克罗恩病和中度至重度活动性溃疡性结肠炎的成年患者，以及患有中度至重度斑块型银屑病和活动性银屑病关节炎的儿科患者。

Pyzchiva® is available in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL single-dose vials for intravenous injection, and 45 mg/0.5 mL subcutaneous single-dose vials.[6]

Pyzchiva® 有45毫克/0.5毫升和90毫克/毫升预填充注射器，130毫克/26毫升单剂量静脉注射瓶，以及45毫克/0.5毫升皮下注射单剂量瓶。[6]

About Hyrimoz® (adalimumab-adaz)

关于Hyrimoz®（阿达木单抗-adaz）

Adalimumab, the active ingredient in Hyrimoz®, is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions — including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis — causing inflammation and tissue destruction in joints, mucosa or skin.

阿达木单抗是Hyrimoz®的活性成分，是一种肿瘤坏死因子（TNF）抑制剂。TNF是一种在某些自身免疫条件下过度产生的蛋白质——包括类风湿关节炎、斑块型银屑病、克罗恩病和溃疡性结肠炎——会导致关节、粘膜或皮肤的炎症和组织破坏。

In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz® targets and blocks the protein that contributes to disease symptoms.[7].

在某些自身免疫性疾病的情况下，免疫系统会损害身体自身的组织。Hyrimoz® 靶向并阻断导致疾病症状的蛋白质。[7]

ABOUT SANDOZ

关于山德士

Sandoz  is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact.

山德士是仿制药和生物类似药的全球领导者，其增长战略受其宗旨驱动：为患者开辟获取药物的途径。来自100个国家的2万多名员工齐心协力，确保山德士提供8亿次患者治疗，为全球医疗保健节省大量开支，并产生更大的社会影响。

Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006.

其约1500种产品的主要组合涵盖了从普通感冒到癌症的疾病。山德士总部位于瑞士巴塞尔，其历史可追溯至1886年。其突破性创新的历史包括1929年的钙尔奇、1951年全球首款口服青霉素，以及2006年全球首个生物类似药。