Samsung Bioepis Applies for Brazilian Approval of Soliris Biosimilar SB12
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Samsung Bioepis has announced that it has submitted an application to the Brazilian Ministry of Health for approval of SB12, a biosimilar of Soliris.
Samsung Bioepis is a leading Korean company that develops and manufactures biopharmaceuticals.
Soliris is a treatment with the generic name eculizumab, used to treat rare diseases such as paroxysmal nocturnal hemoglobinuria. A biosimilar refers to a medicine designed to have similar efficacy and safety to a biopharmaceutical that has already been approved. Biosimilars are often priced lower than the original products, and are known as a way for patients to access treatment more easily.
Samsung Bioepis has been advancing the development and approval processes for biosimilars in various countries. The Brazilian application for SB12 is one such project.
Sources: 의학신문
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