Teva Pharmaceutical Industries has announced that the U.S. Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab). Osteoporosis, a condition characterised by low bone density and an increased risk of fractures, affects around 25% of postmenopausal women in the U.S.

Teva Pharmaceutical Industries宣布，美国食品和药物管理局（FDA）已接受TVB-009P（Prolia®（denosumab）的生物仿制药候选药物）的申请，欧洲药品管理局（EMA）已对其进行验证。骨质疏松症是一种以骨密度低和骨折风险增加为特征的疾病，影响着美国约25%的绝经后妇女。

and the EU. In total, over 165 million women are either in menopause or postmenopause across these regions, with one in three women over 50 estimated to suffer a fracture due to the condition.TVB-009P, a monoclonal antibody, targets RANKL (receptor activator of nuclear factor kappa-B ligand), a protein that plays a key role in bone metabolism.

和欧盟。在这些地区，总共有超过1.65亿女性处于更年期或绝经后，估计每三名50岁以上的女性中就有一名因这种情况而骨折。TVB-009P是一种单克隆抗体，靶向RANKL（核因子κB配体的受体激活剂），RANKL是一种在骨代谢中起关键作用的蛋白质。

It is currently an investigational product and has not yet received regulatory approval.The submissions, which seek approval for all indications currently approved for Prolia, focus on conditions that increase the risk of fracture, such as osteoporosis in postmenopausal women. Decisions from both the FDA and EMA are expected in the second half of 2025.The Biologics License Application (BLA) submitted to the FDA seeks an interchangeability designation, while the Marketing Authorization Application (MAA) was filed with the EMA. These applications are supported by data from the Phase 3 TVB009-IMB-30085 trial, which evaluated the safety and efficacy of TVB-009P compared to Prolia in postmenopausal women with osteoporosis. Additionally, data from a pharmacokinetic study in healthy volunteers confirmed the biosimilar’s similarity to the reference product.Teva, a company with more than 120 years of experience in the pharmaceutical industry, has over 20 biosimilars in its portfolio and pipeline. TVB-009P is the first internally developed biosimilar to be sub.

它目前是一种研究产品，尚未获得监管部门的批准。提交的材料寻求批准目前批准用于Prolia的所有适应症，重点是增加骨折风险的疾病，例如绝经后妇女的骨质疏松症。FDA和EMA预计将在2025年下半年做出决定。提交给FDA的生物制剂许可证申请（BLA）寻求互换性指定，而上市授权申请（MAA）已提交给EMA。这些应用得到了第3阶段TVB009-IMB-30085试验数据的支持，该试验评估了TVB-009P与Prolia相比在绝经后骨质疏松症女性中的安全性和有效性。。Teva是一家在制药行业拥有120多年经验的公司，其投资组合和管道中有20多种生物仿制药。TVB-009P是第一个内部开发的生物仿制药。