Samsung Bioepis Celebrates Soliris Success
Phase I Results For SB12 Eculizumab Biosimilar Candidate Demonstrate Equivalence
Samsung Bioepis has revealed positive Phase I trial results for its SB12 proposed eculizumab biosimilar rival to Soliris.
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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.