价格

SHILPA BIOLOGICALS PRIVATE LIMITED

Plot No.: 532-A, Dharwad, Karnataka, 印度

概览

试验阶段分布

阶段

试验数

占比

3 期

60.0%

1 期

40.0%

试验状态分布

已完成

40.0%

招募中

60.0%

药物批准

暂无批准数据

资讯

Shilpa Medicare and Orion Corporation Partner to Co-Develop Nivolumab Biosimilar for European Market

- Shilpa Biologicals and Finland-based Orion Corporation signed a co-development and exclusive supply agreement for an intravenous nivolumab biosimilar targeting the European market. - The partnership targets a European market opportunity of approximately USD 4.1 billion, based on IQVIA/IMS data showing nivolumab sales in 2025. - Shilpa will lead product development and serve as exclusive long-term manufacturer from its EU-GMP-compliant biologics facility in Dharwad, India. - Orion will hold exclusive rights to register, market, distribute, and sell the product across Europe as the Marketing Authorization holder.

Jul 4, 2026

返回机构列表

SHILPA BIOLOGICALS PRIVATE LIMITED

概览

试验阶段分布

试验状态分布

相关临床试验

该机构主办的试验（5）

To compare the efficacy, safety, and immunogenicity of Aflibercept of Shilpa Biologicals Private Limited (SBPL) with EYLEAÂ® (Aflibercept) of Bayer AG in Wet AMD subjects

A phase-I, open label, randomized, three dose, parallel, safety, pharmacokinetic,pharmacodynamic and immunogenicity assessment study.

To compare the clinical efficacy and safety of shilpa adalimumab with Humaria in patients with active Rheumatoid arthritis.

A phase-I, open label, randomized, three dose, parallel, safety, pharmacokinetic,pharmacodynamic and immunogenicity assessment study.

To compare the clinical efficacy and safety of shilpa adalimumab with Humaria in patients with active Rheumatoid arthritis.

药物批准

资讯

Shilpa Medicare and Orion Corporation Partner to Co-Develop Nivolumab Biosimilar for European Market