ScinoPharm Taiwan has received approval from the US Food and Drug Administration (FDA) for its Glatiramer Acetate (Injection for the treatment of Multiple Sclerosis (MS). With this approval, ScinoPharm becomes the first pharmaceutical company in Taiwan to obtain FDA approval for this product, reflecting Taiwan’s expanding presence in the global pharmaceutical manufacturing landscape.

Multiple Sclerosis affects approximately 2.9 million people worldwide. According to the US National MS Society, there are nearly one million patients in the US alone. Verified Market Reports estimate that the global market size for GA was USD 1.5 billion in 2024, and is projected to reach USD 2.8 billion by 2033.

Since its approval in 1996, GA has been recognised as one of the most challenging complex synthetic polypeptides, globally. To address the unique nature of such products, the US 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 characterised 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 copolymerisation of amino acids, the final product may contain countless potential variants. Therefore, manufacturers must thoroughly validate the consistency and stability of all process parameters. Over 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 (RLD) – Teva Pharmaceuticals's Copaxone.