STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry

STADA和Alvotech在大多数欧洲国家推出了Uzpruvo，这是欧洲第一个批准用于Stelara的生物仿制药。这包括该地区最大的市场，这些市场的定价和报销批准已获得市场准入

The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology1, dermatology and rheumatology.

与欧洲参考分子专利相关的排他性权利到期后，这一开创性的推出立即到来，为患者，医生和付款人提供了尽早获得用于胃肠病，皮肤病和风湿病某些适应症的改变生命的药物的机会。

Launches in further European countries are scheduled over the coming months, following national price approvals, via a fully European supply chain..

根据国家价格批准，未来几个月将通过全欧洲供应链在更多欧洲国家推出。。

In January 2024, Uzpruvo became the first ustekinumab biosimilar to be approved by the European Commission as having equivalent efficacy, safety, pharmacokinetics and immunogenicity to the Stelara reference product. Uzpruvo is indicated for Crohn’s disease and psoriatic arthritis in adults, as well as plaque psoriasis in adults and children aged from 6 years.

2024年1月，Uzpruvo成为欧盟委员会批准的第一种ustekinumab生物仿制药，其功效，安全性，药代动力学和免疫原性与Stelara参考产品相当。Uzpruvo适用于成人克罗恩病和银屑病关节炎，以及成人和6岁以下儿童的斑块状银屑病。

Uzpruvo is currently not approved for the ulcerative colitis indication, since the originator still has exclusivity for this indication..

Uzpruvo目前尚未被批准用于溃疡性结肠炎适应症，因为创始人仍然对该适应症具有排他性。。

Uzpruvo is offered in a pre-filled syringe format featuring a thinner needle than the reference product and is latex-free to minimize the risk of allergic reactions. Uzpruvo was developed, and is manufactured and packaged, entirely within Europe, and has a 36-month shelf life.

Uzpruvo以预填充注射器的形式提供，其针头比参考产品更薄，并且不含乳胶，以最大程度地降低过敏反应的风险。Uzpruvo完全在欧洲开发、制造和包装，保质期为36个月。

Condition: Ps/PsA/Crohns/UC

状态：Ps/PsA/克罗恩/UC

Type: drug

类型：药物