ScinoPharm Taiwan Secures Historic U.S. FDA Approval for Glatiramer Acetate Injection to Treat Multiple Sclerosis

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ScinoPharm Taiwan (TWSE:
1789) announced on January 5, 2026, that it received U.S. FDA approval for Glatiramer Acetate Injection for treating relapsing forms of multiple sclerosis (MS), making it the first Taiwanese company to achieve this for this complex generic drug.12

Glatiramer Acetate, a Non-Biological Complex Drug (NBCD) since 1996 (Copaxone® by Teva), consists of millions of polypeptide chains requiring over 40 advanced analytical techniques for equivalence validation.12

MS affects ~2.9 million worldwide, ~1 million in the U.S.; global market was $1.5B in 2024, projected to $2.8B by 2033, with U.S. market ~$700M.12

ScinoPharm invested heavily in R&D and manufacturing after years of development, positioning it to compete globally and expand beyond APIs into finished products.15

The company plans regulatory submissions and partnerships in Europe, Asia, and emerging markets for further global growth.12

Sources:

1. https://www.barchart.com/story/news/36878677/scinopharm-secures-u-s-fda-approval-for-glatiramer-acetate-injection-for-the-treatment-of-multiple-sclerosis

2. https://www.investing.com/news/company-news/scinopharm-taiwan-receives-fda-approval-for-ms-treatment-93CH-4428767

5. https://www.nasdaq.com/articles/scinopharm-wins-first-fda-approval-glatiramer-acetate-injection-multiple-sclerosis