Taiwanese pharmaceutical company ScinoPharm Taiwan (TWSE: 1789) said on Monday that it has received US Food and Drug Administration approval for its Glatiramer Acetate Injection for the treatment of multiple sclerosis, becoming the first company in Taiwan to achieve this milestone.

Multiple sclerosis affects about 2.9 million people globally, including nearly 1 million patients in the United States, according to the US National MS Society, while Verified Market Reports estimates the global Glatiramer Acetate market was worth USD1.5bn in 2024 and could reach USD2.8bn by 2033.

ScinoPharm said it has invested heavily over several years in process development and manufacturing to streamline production of Glatiramer Acetate, positioning itself to compete in a US market it estimates at about USD700m.

First approved in 1996, Glatiramer Acetate is a complex synthetic polypeptide classified by the FDA as a Non-Biological Complex Drug, requiring a dedicated regulatory pathway due to its lack of a fixed molecular structure or uniform molecular weight. ScinoPharm said more than 40 advanced analytical techniques and biological activity assays were required to demonstrate equivalence to the reference listed drug Copaxone.

The company is now advancing regulatory submissions and partnerships in Europe, Asia and emerging markets to expand its global generic drug product business alongside its established generic API operations.