Samsung Bioepis Expands Sandoz Partnership with Five Next-Gen Biosimilar Candidates

  • Samsung Bioepis and Sandoz signed a global license, development, and commercialization agreement for up to five biosimilar candidates.
  • SB36, referencing Entyvio (vedolizumab), is one of the key candidates under pre-clinical development.
  • Samsung Bioepis will handle development, regulatory registration, and manufacturing, while Sandoz will manage global commercialization excluding China, Hong Kong, Taiwan, Macau, and South Korea.
  • The agreement builds on their existing partnership for PYZCHIVA (ustekinumab) and EPYSQLI™ (eculizumab).

This partnership expands the existing collaboration between Samsung Bioepis and Sandoz, reinforcing their commitment to improving access to biologic medicines. The deal underscores a broader industry trend toward strategic alliances in biosimilar development, aimed at reducing costs and increasing availability of life-changing treatments for patients with debilitating conditions.

Pipeline Progress
The pace at which Samsung Bioepis advances its biosimilar candidates through pre-clinical and clinical trials will determine the timeline for market entry.
Regulatory Approvals
How quickly regulatory bodies approve these biosimilars in key markets will impact their commercialization success.
Market Competition
Whether Samsung Bioepis and Sandoz can effectively compete against established brands like Entyvio (Takeda) and Soliris (Alexion).