Phase 3 trials for Samsung Bioepis’ SB12 begin

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Phase 3 trials for Samsung Bioepis’ SB12 begin

Samsung Bioepis is starting global Phase 3 clinical trials of SB12, a biosimilar candidate.

SB12 is a biosimilar for Soliris, a bio therapy used to treat paroxysmal nocturnal hemoglobinuria. It is made by Boston-based Alexion Pharmaceuticals.

The rare life-threatening disorder is characterized by destruction of red blood cells due to the presence of a defective protein in the body.

Biosimilars are biological products that are approved based on proof that they are highly similar to other approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product but cost less.

The global sales for Soliris hit $3.56 billion last year, with 44.6 percent of that in the United States and 29.1 percent in Europe. Each injection is priced around 6 million won ($4,960) and it usually costs a patient 500 million won a year.

The joint venture between Samsung BioLogics and Cambridge, Mass.-based Biogen said in a statement Monday that it will recruit 50 patients from 10 countries including Korea for the trial, which will run until July 2021. The trial will compare SB12’s efficacy and safety with those of the reference product.

Soliris patents in Europe and the United States expire in June 2020 and March 2021, respectively.

SB12 is primarily competing against ABP 959, which is being developed by Thousand Oaks, Calif.-based Amgen. ABP 959 demonstrated similar safety and immunogenicity to Soliris during Amgen’s Phase 1 study and is being tested for the Phase 3 clinical trials to be completed by April 2021.

As it is targeting the global market for paroxysmal nocturnal hemoglobinuria, Samsung Bioepis signed a licensing agreement with C-Bridge Capital, a Chinese healthcare-dedicated private equity firm, in June this year to expand its biosimilar market share in the country. The companies will push for clinical trials, regulatory approval and commercialization approval on SB12 and two other biosimilars in China.

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