ScinoPharm Taiwan has received approval from the FDA for its Glatiramer Acetate Injection for the treatment of multiple sclerosis (MS), marking the company’s first U.S. finished-dosage product approval and its entry into the complex generics market for MS therapies. The product is a generic version of glatiramer acetate, a non‑biological complex drug (NBCD) used for relapsing forms of MS, including clinically isolated syndrome, relapsing‑remitting disease and active secondary progressive disease in adults.
ScinoPharm is the first Taiwan‑based pharmaceutical company to obtain U.S. FDA approval for glatiramer acetate injection, a therapy regarded as one of the most challenging synthetic polypeptides to develop and manufacture due to its heterogeneous peptide mixture and demanding analytical requirements. The company reports that more than 40 advanced analytical methods and extensive process controls were deployed to demonstrate equivalence to the reference product Copaxone (Teva’s glatiramer acetate).
The U.S. market for glatiramer acetate is estimated at roughly USD 700 million annually within a broader global market of about USD 1.5 billion in 2024, projected to reach USD 2.8 billion by 2033. ScinoPharm plans additional regulatory filings and partnerships in Europe, Asia and emerging markets as it expands beyond its existing position as a generic active pharmaceutical ingredient supplier into finished dosage forms for neurological and other complex conditions.
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