Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations in the United Kingdom (UK) for YESINTEK®, a biosimilar of Ustekinumab.

Biocon Biologics Ltd（BBL）是一家全球一体化的生物仿制药公司，也是Biocon Ltd的子公司，今天宣布，英国药品和健康产品管理局（MHRA）已授予其乌司奴单抗生物类似药YESINTEK®在英国（UK）的上市许可。

YESINTEK® is indicated for the treatment of adults and children from the age of 6 years and older with moderate to severe plaque psoriasis, and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease. Clinical data from the trial program demonstrated that our Ustekinumab biosimilar has comparable safety and efficacy to the originator product..

YESINTEK® 适用于治疗 6 岁及以上中度至重度斑块型银屑病成人和儿童患者，以及活动性银屑病关节炎或中度至重度活动性克罗恩病成人患者。试验项目的临床数据表明，我们的乌司奴单抗生物类似药与原研产品具有相当的安全性和有效性。

In Europe, the European Commission (EC) recently granted marketing authorisation for Ustekinumab, allowing its commercialization in all European Union (EU) member states and the European Economic Area (EEA).

在欧洲，欧洲委员会（EC）最近授予了乌司奴单抗的上市许可，允许其在所有欧盟（EU）成员国和欧洲经济区（EEA）进行商业化。

Source: biocon.com

来源：biocon.com