Samsung Bioepis Moves Forward With Soliris Rival
Completes Phase III Trial For SB12 Proposed Eculizumab Biosimilar
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.
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Samsung Bioepis has taken a further step towards registering its SB12 eculizumab biosimilar after its filing for the Soliris rival was accepted for review by the European Medicines Agency.
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.
In the wake of parent company Samsung Biologics completing its full acquisition of Samsung Bioepis, the Korea-based biosimilars player has told Generics Bulletin that it will be a “more robust company,” as it applies more rigorous standards to replenishing its pipeline of biosimilar candidates.