Samsung Bioepis has completed the global phase 3 clinical trials of its SB12, a biosimilar drug of Soliris (ingredient: eculizumab), for treating paroxysmal nocturnal hemoglobinuria (PNH).

Samsung Bioepis researchers work in the company’s laboratory to develop biosimilar drugs for various diseases.
Samsung Bioepis researchers work in the company’s laboratory to develop biosimilar drugs for various diseases.

The company received the last patient to end the clinical trials of SB12 and updated the study in clinicaltrials.gov, run by the U.S. National Institutes of Health, on Monday.

The clinical trials began in August 2019 to compare the efficacy and safety between SB12 and Soliris in 50 PNH patients from eight countries, including Korea.

Soliris is an expensive treatment developed by Alexion, a U.S. pharmaceutical company, for treating rare diseases, such as PNH and atypical hemolytic uremic syndrome (aHUS). Its global sales reached about $4.06 billion in 2020.

According to Health Insurance Review and Assessment Service’s standard list of drug pricing and reimbursement as of October 2021, the yearly cost for an adult using Soliris could reach up to hundreds of millions of won depending on the dosage.

“We will try to improve patients’ access to expensive biopharmaceuticals to help solve their unmet medical needs by developing biosimilar drug SB12,” a Samsung Bioepis official said.

Samsung Bioepis has 10 biosimilar products and pipelines for autoimmune disease, cancer, blood disease, ophthalmic disease, and skeletal disease. The company is expanding its pipeline portfolio and growing into a developer to lead the global biosimilar market.

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