ScinoPharm wins US approval for complex MS generic
Taiwanese drugmaker ScinoPharm (TWSE: 1789) has secured approval from the US Food and Drug Administration for its glatiramer acetate injection, a generic treatment for multiple sclerosis. The company said it is the first pharmaceutical group in Taiwan to obtain US clearance for this complex injectable product.
The approval opens the door to the US glatiramer acetate market, long dominated by Copaxone (glatiramer acetate), originally developed by Israeli drugmaker Teva Pharmaceutical (NYSE: TEVA). ScinoPharm said the decision reflects several years of investment in process development, analytics, and manufacturing reproducibility.
Glatiramer acetate is classed as a non-biological complex drug, meaning it is not a single, well-defined molecule but a mixture of many peptide chains. This complexity has historically limited the number of companies able to meet US regulatory standards for equivalence and quality control.
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