Samsung Bioepis is speeding up to develop a biosimilar of Soliris (eculizumab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH).
The Ministry of Food and Drug Safety on Wednesday gave the nod to the company to go ahead with a phase-3 trial that compares Samsung Bioepis’ biosimilar candidate SB12 with
|Soliris, Alexion Pharmaceuticals’ treatment for paroxysmal nocturnal hemoglobinuria|
Alexion Pharmaceuticals’ original drug Soliris.
Soliris obtained local approval in 2010 and received expanded indication for the atypical hemolytic uremic syndrome (aHUS) in 2016.
The trial will be a randomized, double-blind, multinational, multicenter, and phase-3 study to compare the efficacy, safety, pharmacokinetics, and immunogenicity of SB12 with those of Soliris.
The test will be on 50 patients with PNH around the world, including three Koreans, and it will take place at Samsung Medical Center in Korea.
Samsung Bioepis is also seeking to market SB12 in China. In February, the company signed a deal with Chinese private equity firm C-Bridge Capital to sell its biosimilar products in China.
Under the deal, the two companies will push for clinical trials, regulatory approval, and commercialization of three biosimilars – Herceptin biosimilar SB3 (trastuzumab), Lucentis biosimilar SB11 (ranibizumab), and SB12 – in China.