Samsung Bioepis Sees Success With Soliris Biosimilar
SB12 Eculizumab Candidate Demonstrates Equivalence In Phase III Trial
Samsung Bioepis has reported positive Phase III data for its SB12 proposed eculizumab biosimilar to Soliris, with the product showing equivalence in efficacy, safety, PK, PD and immunogenicity.
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Samsung Bioepis has revealed positive Phase I trial results for its SB12 proposed eculizumab biosimilar rival to Soliris.
Samsung Bioepis has confirmed completion of its Phase III trial for a proposed biosimilar to Soliris, putting it ahead of rival developer Amgen which has negotiated a date-certain US launch.
Alexion Pharmaceuticals’ Soliris (eculizumab) blockbuster represents a significant opportunity for biosimilar sponsors around the globe. Ahead of anticipated US competition in 2025, the originator has added a new formulation for next-generation product Ultomiris (ravulizumab-cwvz).