ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis

ScinoPharm Taiwan (TWSE: 1789) today announced a landmark achievement in the global pharmaceutical landscape, securing U.S. Food and Drug Administration (FDA) approval for Glatiramer Acetate Injection, a treatment for Multiple Sclerosis (MS), making it the only pharmaceutical company in Taiwan to achieve this historic milestone. This achievement underscores ScinoPharm's leadership in complex generics and highlights Taiwan's growing recognition as a trusted contributor to the global pharmaceutical industry.

Multiple Sclerosis affects approximately 2.9 million people worldwide. According to the U.S. National MS Society, there are nearly 1 million patients in the United States alone. Verified Market Reports estimates that the global market size for Glatiramer Acetate was USD 1.5 billion in 2024 and is projected to reach USD 2.8 billion by 2033. In response to this significant opportunity, ScinoPharm has invested heavily in its process development and manufacturing capabilities, successfully mastering this high-barrier process after years of dedicated R&D and ultimately positioning itself to compete in its USD ~700 million U.S. market.

Pioneering R&D: ScinoPharm Scientists Decode the Complexity of Glatiramer Acetate Manufacturing

Since its approval in 1996, Glatiramer Acetate (GA) has been recognized as one of the most challenging complex synthetic polypeptides globally. To address the unique nature of such products, the U.S. FDA even established a dedicated regulatory pathway for Non-Biological Complex Drugs (NBCDs).

Unlike conventional small molecules, GA is not a single defined entity but a peptide copolymer mixture composed of millions of polypeptide chains with varying lengths and amino acid sequences. It lacks a fixed molecular structure, a specific sequence, and a uniform molecular weight, so it cannot be fully characterized using standard analytical methods typically applied to biologics such as monoclonal antibodies. This complexity results in significant challenges for quality control, manufacturing reproducibility, and equivalence assessment.

Due to the inherent diversity generated through the random copolymerization of amino acids, the final product may contain countless potential variants. Therefore, manufacturers must thoroughly validate the consistency and stability of all process parameters. More than 40 advanced analytical techniques, supported by statistical modeling, are required to establish product equivalence with biological activity assays necessary to confirm that the final product is indeed comparable to the reference listed drug (Teva Pharmaceutical's Copaxone^®).

Even today, only a handful of companies worldwide possess the scientific and manufacturing capabilities required to produce and commercialize Glatiramer Acetate. Leveraging its integrated strengths in R&D, manufacturing, and advanced analytical capabilities, ScinoPharm has taken the lead in Taiwan by successfully obtaining U.S. FDA approval for this product. This achievement not only underscores ScinoPharm's world-class innovation capabilities, but also validates its competitiveness alongside leading global pharmaceutical companies in a multibillion-dollar market, injecting powerful momentum into the company's global expansion and sustained growth.

Vision for the Future: Beyond the U.S. Horizon

While the U.S. FDA approval marks a historic first, ScinoPharm is already executing its next phase of global growth. The company is actively advancing regulatory submissions and forging strategic partnerships across Europe, Asia, and emerging markets to broaden its international presence in the generic drug product market and build on its already strong position on the generic API front. Guided by its mission—"We apply our expertise with rigorous standards and continuous improvements to deliver safe, effective, and high-quality medicines."—the company will continue transforming scientific innovation into meaningful outcomes for patients worldwide.